xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992155</url>
    </required_header>
    <id_info>
      <org_study_id>TAK-279-1003</org_study_id>
      <nct_id>NCT05992155</nct_id>
    </id_info>
    <brief_title>A Study of TAK-279 in Adults With or Without Kidney Problems</brief_title>
    <official_title>An Open-Label, Phase 1 Study to Compare Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of TAK-279 in Subjects With or Without Renal Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Takeda</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main aim of this study is to find out how the body processes 1 dose of TAK-279&#xD;
        (pharmacokinetics) in participants with kidney problems compared to participants without&#xD;
        kidney problems. Other aims are to check for side effects from TAK-279 and to learn how well&#xD;
        participants tolerate 1 dose of TAK-279.&#xD;
  &#xD;
        The participants will need to stay at the clinic for 11 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the&#xD;
        pharmacokinetics (PK), safety, and tolerability of TAK-279 in participants with severe (Part&#xD;
        A) and moderate (Part B) renal impairment (RI) compared to healthy participants with normal&#xD;
        renal function.&#xD;
  &#xD;
        The study will enroll up to 48 patients. Participants will be assigned to following study&#xD;
        cohorts in Parts A and B to receive single-dose of TAK-279:&#xD;
  &#xD;
          -  Cohort 1, Severe RI: TAK-279 50 mg&#xD;
  &#xD;
          -  Cohort 2, Normal Renal Function: TAK-279 50 mg&#xD;
  &#xD;
          -  Cohort 3, Moderate RI: TAK-279 50 mg&#xD;
  &#xD;
        If the decision to proceed to Part B is made, participants with moderate RI will be enrolled&#xD;
        in Cohort 3 of the study. Participants in Cohort 3 will receive single-dose of TAK-279 50 mg&#xD;
        and will be compared with the participants who meet the matching criteria of Cohort 2 with&#xD;
        normal renal function.&#xD;
  &#xD;
        This multi-center trial will be conducted in the United States. The overall duration of the&#xD;
        study is up to 44 days. Participants will be followed up for 14 days after the last dose of&#xD;
        study drug for a follow-up assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 9, 2023</start_date>
    <completion_date type="Anticipated">January 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 18, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cmax: Maximum Observed Plasma Concentration for TAK-279</measure>
      <time_frame>Predose and at multiple time points post dose up to Day 10</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279</measure>
      <time_frame>Predose and at multiple time points post dose up to Day 10</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279</measure>
      <time_frame>Predose and at multiple time points post dose up to Day 10</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>From study start through 14 days after last dose administration (up to approximately 42 days)</time_frame>
      <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Adverse Events of Special Interest (AESIs)</measure>
      <time_frame>From study start through 14 days after last dose administration (up to approximately 42 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Markedly Abnormal Values for Vital Signs</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Markedly Abnormal Laboratory Values</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Physical Examination Findings</measure>
      <time_frame>Up to Day 10</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Renal Impairment</condition>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Cohort 1, Severe RI: TAK-279 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2, Normal Renal Function: TAK-279 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3, Moderate RI: TAK-279 50 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TAK-279</intervention_name>
      <description>TAK-279 capsules.</description>
      <arm_group_label>Cohort 1, Severe RI: TAK-279 50 mg</arm_group_label>
      <arm_group_label>Cohort 2, Normal Renal Function: TAK-279 50 mg</arm_group_label>
      <arm_group_label>Cohort 3, Moderate RI: TAK-279 50 mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A. Participants with RI:&#xD;
  &#xD;
          The participants must fulfill the following inclusion criteria to be eligible for&#xD;
          participation in the study (participants who do not qualify based on a reversible condition&#xD;
          or mild intercurrent illness may be re-screened after the condition is resolved. Screening&#xD;
          tests may be repeated if in the Investigator's opinion the test needs to be repeated):&#xD;
  &#xD;
            1. Understands the study procedures in the informed consent form (ICF), and be willing&#xD;
               and able to comply with the protocol.&#xD;
  &#xD;
            2. Adult male or female participant aged ≥18 years, at screening.&#xD;
  &#xD;
            3. Has a body weight greater than 50 kg and has a body mass index (BMI) ≥18.0 and ≤39.0&#xD;
               kilograms per meters squared (kg/m^2), at screening.&#xD;
  &#xD;
            4. Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent&#xD;
               [including electronic cigarettes]) before screening. Participant must agree to smoke&#xD;
               no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the&#xD;
               7 days prior to TAK-279 dosing.&#xD;
  &#xD;
            5. Aside from RI, be sufficiently healthy for study participation based upon medical&#xD;
               history, physical examination, vital signs, electrocardiograms (ECGs), and screening&#xD;
               clinical laboratory profiles, as deemed by the Investigator or designee, including:&#xD;
  &#xD;
                 -  Supine blood pressure (BP) is ≥90/40 mmHg (asymptomatic) and ≤180/100 mmHg, at&#xD;
                    screening;&#xD;
  &#xD;
                 -  Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening;&#xD;
  &#xD;
                 -  ECG findings are considered normal or not clinically significant by the&#xD;
                    Investigator or designee at the screening visit.&#xD;
  &#xD;
            6. Estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal&#xD;
               Disease (MDRD) equation at screening as follows,&#xD;
  &#xD;
                 -  Severe RI: &lt;30 millilitres per minute (mL/min), not on dialysis;&#xD;
  &#xD;
                 -  Moderate RI: 30-59 mL/min.&#xD;
  &#xD;
            7. Has chronic RI for at least 3 months before screening, and the RI must be stable,&#xD;
               i.e., no significant changes (i.e., ≥30%) in renal function in the 30 days preceding&#xD;
               screening (or since the last visit if within 6 months before screening) and treatment&#xD;
               with stable doses of medication.&#xD;
  &#xD;
            8. Female participants of childbearing potential agree to comply with any acceptable&#xD;
               contraceptive requirements of the protocol.&#xD;
  &#xD;
          B. Healthy Participants:&#xD;
  &#xD;
            1. Understands the study procedures in the ICF, and be willing and able to comply with&#xD;
               the protocol.&#xD;
  &#xD;
            2. Adult male or female participants aged ≥18 years, at screening. Participant will be&#xD;
               matched by age (±10 years) and sex to a participant with severe RI (Part A) and/or a&#xD;
               participant with moderate RI (Part B).&#xD;
  &#xD;
            3. Has a body weight greater than 50 kg and has a BMI ≥18.0 and ≤39.0 kg/m2, at&#xD;
               screening. Participant will be matched by body weight (±15 kg) to a participant with&#xD;
               severe RI (Part A) and/or a participant with moderate RI (Part B).&#xD;
  &#xD;
            4. Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent&#xD;
               [including electronic cigarettes]) before screening. Participant must agree to smoke&#xD;
               no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the&#xD;
               7 days prior to TAK-279 dosing.&#xD;
  &#xD;
            5. Medically healthy with no clinically significant medical history, physical&#xD;
               examination, vital signs, ECGs, and screening clinical laboratory profiles, as deemed&#xD;
               by the Investigator or designee, including:&#xD;
  &#xD;
                 -  Supine BP is ≥90/40 mmHg and ≤150/95 mmHg, at screening;&#xD;
  &#xD;
                 -  Supine PR is ≥40 bpm and ≤99 bpm, at screening;&#xD;
  &#xD;
                 -  QT interval corrected for heart rate using Fridericia's formula (QTcF) is ≤450&#xD;
                    millisecond (msec) (males) or ≤470 msec (females) and ECG findings considered&#xD;
                    normal or not clinically significant by the Investigator or designee, at&#xD;
                    screening;&#xD;
  &#xD;
                 -  Liver function tests including alanine aminotransferase (ALT), aspartate&#xD;
                    aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin within&#xD;
                    the upper limit of normal (ULN) at screening and at check-in.&#xD;
  &#xD;
            6. eGFR based on the MDRD equation at screening as follows:&#xD;
  &#xD;
                 -  Normal renal function: ≥90 mL/min.&#xD;
  &#xD;
            7. Female participants of childbearing potential agree to comply with any acceptable&#xD;
               contraceptive requirements of the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A. Participants with RI:&#xD;
  &#xD;
          The participant must be excluded from participating in the study if the participant:&#xD;
  &#xD;
            1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
               of screening or expected during the conduct of the study.&#xD;
  &#xD;
            2. Has history or presence of clinically significant medical or psychiatric condition or&#xD;
               disease (aside from RI) in the opinion of the Investigator or designee.&#xD;
  &#xD;
            3. Has history of any illness that, in the opinion of the Investigator or designee, might&#xD;
               confound the results of the study or poses an additional risk to the participant by&#xD;
               their participation in the study.&#xD;
  &#xD;
            4. Has a history of any of the following:&#xD;
  &#xD;
                 -  Active infection or febrile illness within 7 days prior to dosing, as assessed by&#xD;
                    the Investigator or designee.&#xD;
  &#xD;
                 -  Symptoms suggestive of systemic or invasive infection requiring hospitalization&#xD;
                    or treatment within 8 weeks prior to dosing.&#xD;
  &#xD;
                 -  Chronic or recurrent bacterial disease, including but not limited to chronic&#xD;
                    pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or&#xD;
                    chronic skin ulcerations/infections or fungal infections (except superficial&#xD;
                    nailbed mycosis).&#xD;
  &#xD;
                 -  An infected joint prosthesis unless that prosthesis has been removed or replaced&#xD;
                    within 60 days prior to dosing.&#xD;
  &#xD;
                 -  Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis,&#xD;
                    coccidiomycosis).&#xD;
  &#xD;
                 -  Cancer or lymphoproliferative disease within 5 years prior to dosing, with the&#xD;
                    exception of successfully treated nonmetastatic cutaneous squamous cell or basal&#xD;
                    cell carcinoma and/or localized carcinoma in situ of the cervix is not&#xD;
                    exclusionary.&#xD;
  &#xD;
                 -  Known or suspected condition/illness that is consistent with compromised&#xD;
                    immunity, including but not limited to any identified congenital or acquired&#xD;
                    immunodeficiency; splenectomy.&#xD;
  &#xD;
                 -  Liver or other solid organ transplant.&#xD;
  &#xD;
            5. Has had a failed renal transplant or a nephrectomy.&#xD;
  &#xD;
            6. Has history or presence of alcoholism and/or drug abuse within the past 6 months prior&#xD;
               to dosing, as determined by the Investigator or designee.&#xD;
  &#xD;
            7. Has history or presence of clinically significant hypersensitivity or idiosyncratic&#xD;
               reaction to the study drug or related compounds.&#xD;
  &#xD;
            8. Female with a positive pregnancy test at screening or check-in or who is lactating.&#xD;
  &#xD;
            9. Has positive results for the urine or saliva drug screen at screening or check-in,&#xD;
               unless the positive drug screen is due to prescription drug use that is approved by&#xD;
               the Investigator or designee and Sponsor.&#xD;
  &#xD;
           10. Has positive results for urine or breath alcohol screen at screening or check-in.&#xD;
  &#xD;
           11. Unable to refrain from or anticipates the use of any medication or substance&#xD;
               (including prescription or over-the-counter, vitamin supplements, natural or herbal&#xD;
               supplements) for the prohibited time period.&#xD;
  &#xD;
           12. Has been on a diet incompatible with the on-study diet, in the opinion of the&#xD;
               Investigator or designee, within the 30 days prior to dosing and throughout the study.&#xD;
  &#xD;
           13. Has made a donation of blood or had significant blood loss within 56 days prior to&#xD;
               dosing.&#xD;
  &#xD;
           14. Has made a plasma donation within 7 days prior to dosing.&#xD;
  &#xD;
           15. Participated in another clinical study within 30 days prior to dosing. The 30-day&#xD;
               window will be derived from the date of the last dosing in the previous study to Day 1&#xD;
               of the current study.&#xD;
  &#xD;
           16. Herpes infections:&#xD;
  &#xD;
                 -  Has active herpes virus infection, including herpes zoster or herpes simplex 1&#xD;
                    and 2 (demonstrated on physical examination and/or medical history) at screening&#xD;
                    or Day -1.&#xD;
  &#xD;
                 -  History of serious herpetic infection that includes any episode of disseminated&#xD;
                    disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic&#xD;
                    herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).&#xD;
  &#xD;
           17. Positive results for non-herpetic viral diseases at screening:&#xD;
  &#xD;
                 -  Hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV&#xD;
                    ribonucleic acid (RNA) (nucleic acid test or polymerase chain reaction (PCR));&#xD;
  &#xD;
                 -  Hepatitis B surface antigen (HBsAg)+, hepatitis B virus deoxyribonucleic acid&#xD;
                    (DNA), or anti-hepatitis B core antibody without concurrent positive hepatitis B&#xD;
                    surface antibody (HBcAb+ and HBsAb-);&#xD;
  &#xD;
                 -  Human immunodeficiency virus (HIV).&#xD;
  &#xD;
                 -  Tuberculosis (TB):&#xD;
  &#xD;
                      -  History of active TB infection, regardless of treatment status.&#xD;
  &#xD;
                      -  Has signs or symptoms of active TB (including but not limited to chronic&#xD;
                         fever, chronic productive cough, night sweats, or weight loss) as judged by&#xD;
                         the Investigator or designee.&#xD;
  &#xD;
                      -  Has evidence of latent tuberculosis infection (LTBI) as evidenced by a&#xD;
                         positive QuantiFERON-TB Gold (QFT) result OR 2 indeterminant QFT results and&#xD;
                         does not have documentation of appropriate LTBI prophylaxis. Participant&#xD;
                         remains eligible if he or she can provide documentation of prior and&#xD;
                         complete treatment for LTBI (appropriate in duration and type per current&#xD;
                         local country guidelines).&#xD;
  &#xD;
                      -  Has had any imaging study during or 6 months prior to screening, including&#xD;
                         x-ray, chest computed tomography, magnetic resonance imaging, or other chest&#xD;
                         imaging suggesting evidence of current active or a history of active TB.&#xD;
  &#xD;
          B. For Healthy Participants:&#xD;
  &#xD;
          The participant must be excluded from participating in the study if the participant:&#xD;
  &#xD;
            1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
               of screening or expected during the conduct of the study.&#xD;
  &#xD;
            2. Has history or presence of clinically significant medical or psychiatric condition or&#xD;
               disease in the opinion of the Investigator or designee.&#xD;
  &#xD;
            3. Has history of any illness that, in the opinion of the Investigator or designee, might&#xD;
               confound the results of the study or poses an additional risk to the participant by&#xD;
               their participation in the study.&#xD;
  &#xD;
            4. Has a history of any of the following:&#xD;
  &#xD;
                 -  Active infection or febrile illness within 7 days prior to dosing, as assessed by&#xD;
                    the Investigator or designee.&#xD;
  &#xD;
                 -  Symptoms suggestive of systemic or invasive infection requiring hospitalization&#xD;
                    or treatment within 8 weeks prior to dosing.&#xD;
  &#xD;
                 -  Chronic or recurrent bacterial disease, including but not limited to chronic&#xD;
                    pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or&#xD;
                    chronic skin ulcerations/infections or fungal infections (except superficial&#xD;
                    nailbed mycosis).&#xD;
  &#xD;
                 -  An infected joint prosthesis unless that prosthesis has been removed or replaced&#xD;
                    within 60 days prior to dosing.&#xD;
  &#xD;
                 -  Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis,&#xD;
                    coccidiomycosis).&#xD;
  &#xD;
                 -  Cancer or lymphoproliferative disease within 5 years prior to dosing, with the&#xD;
                    exception of successfully treated nonmetastatic cutaneous squamous cell or basal&#xD;
                    cell carcinoma and/or localized carcinoma in situ of the cervix is not&#xD;
                    exclusionary.&#xD;
  &#xD;
                 -  Known or suspected condition/illness that is consistent with compromised&#xD;
                    immunity, including but not limited to any identified congenital or acquired&#xD;
                    immunodeficiency; splenectomy.&#xD;
  &#xD;
                 -  Liver or other solid organ transplant.&#xD;
  &#xD;
            5. Has history or presence of alcoholism and/or drug abuse within the past 2 years prior&#xD;
               to dosing, as determined by the Investigator or designee.&#xD;
  &#xD;
            6. Has history or presence of clinically significant hypersensitivity or idiosyncratic&#xD;
               reaction to the study drug or related compounds.&#xD;
  &#xD;
            7. Female with a positive pregnancy test at screening or check-in, or who is lactating.&#xD;
  &#xD;
            8. Has positive results for the urine or saliva drug screen at screening or check-in,&#xD;
               unless the positive drug screen is due to prescription drug use that is approved by&#xD;
               the Investigator or designee and Sponsor.&#xD;
  &#xD;
            9. Has positive results for urine or breath alcohol screen at screening or check-in.&#xD;
  &#xD;
           10. Unable to refrain from or anticipates the use of any medication or substance&#xD;
               (including prescription or over-the-counter, vitamin supplements, natural or herbal&#xD;
               supplements) for the prohibited time period.&#xD;
  &#xD;
           11. Has been on a diet incompatible with the on-study diet, in the opinion of the&#xD;
               Investigator or designee, within the 30 days prior to dosing and throughout the study.&#xD;
  &#xD;
           12. Has made a donation of blood or had significant blood loss within 56 days prior to&#xD;
               dosing.&#xD;
  &#xD;
           13. Has made a plasma donation within 7 days prior to dosing.&#xD;
  &#xD;
           14. Participated in another clinical study within 30 days prior to dosing. The 30-day&#xD;
               window will be derived from the date of the last dosing in the previous study to Day 1&#xD;
               of the current study.&#xD;
  &#xD;
           15. Herpes infections:&#xD;
  &#xD;
                 -  Has active herpes virus infection, including herpes zoster or herpes simplex 1&#xD;
                    and 2 (demonstrated on physical examination and/or medical history) at screening&#xD;
                    or Day -1.&#xD;
  &#xD;
                 -  History of serious herpetic infection that includes any episode of disseminated&#xD;
                    disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic&#xD;
                    herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years).&#xD;
  &#xD;
           16. Positive results for non-herpetic viral diseases at screening:&#xD;
  &#xD;
                 -  HCV antibody and a positive confirmatory test result for HCV RNA (nucleic acid&#xD;
                    test or PCR);&#xD;
  &#xD;
                 -  HBsAg+, hepatitis B virus DNA, or anti-hepatitis B core antibody without&#xD;
                    concurrent positive hepatitis B surface antibody (HBcAb+ and HBsAb-);&#xD;
  &#xD;
                 -  HIV;&#xD;
  &#xD;
                 -  TB:&#xD;
  &#xD;
                      -  History of active TB infection, regardless of treatment status.&#xD;
  &#xD;
                      -  Has signs or symptoms of active TB (including but not limited to chronic&#xD;
                         fever, chronic productive cough, night sweats, or weight loss) as judged by&#xD;
                         the Investigator or designee.&#xD;
  &#xD;
                      -  Has evidence of LTBI as evidenced by a positive QFT result OR 2&#xD;
                         indeterminant QFT results and does not have documentation of appropriate&#xD;
                         LTBI prophylaxis. Participant remains eligible if he or she can provide&#xD;
                         documentation of prior and complete treatment for LTBI (appropriate in&#xD;
                         duration and type per current local country guidelines).&#xD;
  &#xD;
                      -  Has had any imaging study during or 6 months prior to screening, including&#xD;
                         x-ray, chest computed tomography, magnetic resonance imaging, or other chest&#xD;
                         imaging suggesting evidence of current active or a history of active TB.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Takeda</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Takeda Contact</last_name>
      <phone>+1-877-825-3327</phone>
      <email>medinfoUS@takeda.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Pharmacology of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33014</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
      </contact>
      <investigator>
        <last_name>Alfredo Fernandez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Orlando Clinical Research Center</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32809</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
      </contact>
      <investigator>
        <last_name>Thomas Marbury</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Research by Design</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60643</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
      </contact>
      <investigator>
        <last_name>April R. Kennedy</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Drug Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Renal Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992155
  org study id: TAK-279-1003
  nct id: NCT05992155
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The main aim of this study is to find out how the body processes 1 dose of TAK-279
        (pharmacokinetics) in participants with kidney problems compared to participants without
        kidney problems. Other aims are to check for side effects from TAK-279 and to learn how well
        participants tolerate 1 dose of TAK-279.
  
        The participants will need to stay at the clinic for 11 days.
  The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the
        pharmacokinetics (PK), safety, and tolerability of TAK-279 in participants with severe (Part
        A) and moderate (Part B) renal impairment (RI) compared to healthy participants with normal
        renal function.
  
        The study will enroll up to 48 patients. Participants will be assigned to following study
        cohorts in Parts A and B to receive single-dose of TAK-279:
  
          -  Cohort 1, Severe RI: TAK-279 50 mg
  
          -  Cohort 2, Normal Renal Function: TAK-279 50 mg
  
          -  Cohort 3, Moderate RI: TAK-279 50 mg
  
        If the decision to proceed to Part B is made, participants with moderate RI will be enrolled
        in Cohort 3 of the study. Participants in Cohort 3 will receive single-dose of TAK-279 50 mg
        and will be compared with the participants who meet the matching criteria of Cohort 2 with
        normal renal function.
  
        This multi-center trial will be conducted in the United States. The overall duration of the
        study is up to 44 days. Participants will be followed up for 14 days after the last dose of
        study drug for a follow-up assessment.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Cmax: Maximum Observed Plasma Concentration for TAK-279
  time frame: Predose and at multiple time points post dose up to Day 10
  measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
  time frame: Predose and at multiple time points post dose up to Day 10
  measure: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
  time frame: Predose and at multiple time points post dose up to Day 10
  measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
  time frame: From study start through 14 days after last dose administration (up to approximately 42 days)
  description: An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
  measure: Number of Participants With Adverse Events of Special Interest (AESIs)
  time frame: From study start through 14 days after last dose administration (up to approximately 42 days)
  measure: Number of Participants With Markedly Abnormal Values for Vital Signs
  time frame: Up to Day 10
  measure: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings
  time frame: Up to Day 10
  measure: Number of Participants With Markedly Abnormal Laboratory Values
  time frame: Up to Day 10
  measure: Number of Participants With Clinically Significant Physical Examination Findings
  time frame: Up to Day 10
  arm group label: Cohort 1, Severe RI: TAK-279 50 mg
  arm group type: Experimental
  description: Participants with severe RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
  arm group label: Cohort 2, Normal Renal Function: TAK-279 50 mg
  arm group type: Experimental
  description: Participants with normal renal function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.
  arm group label: Cohort 3, Moderate RI: TAK-279 50 mg
  arm group type: Experimental
  description: Participants with moderate RI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study.
  intervention type: Drug
  intervention name: TAK-279
  description: TAK-279 capsules.
  arm group label: Cohort 1, Severe RI: TAK-279 50 mg
  arm group label: Cohort 2, Normal Renal Function: TAK-279 50 mg
  arm group label: Cohort 3, Moderate RI: TAK-279 50 mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Study Director
  role: Study Director
  affiliation: Takeda
  last name: Takeda Contact
  phone: +1-877-825-3327
  email: medinfoUS@takeda.com
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Renal Insufficiency
  sharing ipd: Yes
  ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
  ipd url: https://vivli.org/ourmember/takeda/