<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/NCT04452006</url>
  </required_header>
  <id_info>
    <org_study_id>ID-088-101</org_study_id>
    <nct_id>NCT04452006</nct_id>
  </id_info>
  <brief_title>A Study in Healthy Subjects to Investigate the Safety and Tolerability of ACT- 541478 as Well as What ACT-541478 Does to the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-541478</brief_title>
  <official_title>Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Idorsia Pharmaceuticals Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Idorsia Pharmaceuticals Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well&#xD;
      as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid&#xD;
      of of ACT-541478&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on interim analysis, the Sponsor decided to terminate the study prematurely.&#xD;
  </why_stopped>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">April 20, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Part A: Single-ascending dose study in healthy male subjects (including investigation of the effect of food); Part B: Single-dose, three-way crossover study in healthy male subjects to investigate specific/additional parameters related to safety and tolerability; Part C: Multiple-ascending dose study in healthy male and female subjects (including healthy male and female elderly subjects).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-emergent (serious) AEs</measure>
    <time_frame>From (first) study treatment administration up to 96 h after last study treatment administration in the corresponding period (if applicable). Total duration: up to 5 days.</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): Cmax</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): tmax</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): AUC0-inf</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): t½</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): Cmax</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): tmax</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): AUCτ</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): t1/2</measure>
    <time_frame>Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Specific/additional parameters related to safety and tolerability - Part B</measure>
    <time_frame>At various timepoints. Total duration: up to 5 days.</time_frame>
  </other_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A (SAD) - A1, ACT-541478 10 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (SAD) - A2, ACT-541478 30 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (SAD) - A4, ACT-541478 300 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A (SAD) - A5, ACT-541478 1000 mg fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAD = single ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - B1-3, ACT-541478 low or high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C (MAD) - C1, ACT-541478 30 mg, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAD = multiple ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C (MAD) - C2, ACT-541478 100 mg, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAD = multiple ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C (MAD) - C3, ACT-541478 300 mg, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MAD = multiple ascending dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C (Elderly) E1, ACT-541478, fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 10 mg</intervention_name>
    <description>ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.</description>
    <arm_group_label>Part A (SAD) - A1, ACT-541478 10 mg fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 30 mg</intervention_name>
    <description>ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.</description>
    <arm_group_label>Part A (SAD) - A2, ACT-541478 30 mg fasted</arm_group_label>
    <arm_group_label>Part C (MAD) - C1, ACT-541478 30 mg, fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 100 mg</intervention_name>
    <description>ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 50 mg.</description>
    <arm_group_label>Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted</arm_group_label>
    <arm_group_label>Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed</arm_group_label>
    <arm_group_label>Part C (MAD) - C2, ACT-541478 100 mg, fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 300 mg</intervention_name>
    <description>ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 50 mg and 250 mg.</description>
    <arm_group_label>Part A (SAD) - A4, ACT-541478 300 mg fasted</arm_group_label>
    <arm_group_label>Part C (MAD) - C3, ACT-541478 300 mg, fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 1000 mg</intervention_name>
    <description>ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 250 mg.</description>
    <arm_group_label>Part A (SAD) - A5, ACT-541478 1000 mg fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 high or low dose (or placebo)</intervention_name>
    <description>Cross-over design: ACT-541478 will be provided in HPMC capsules for oral administration at high or low dose strengths (to be defined after completion of Part A).</description>
    <arm_group_label>Part B - B1-3, ACT-541478 low or high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACT-541478 dose E1</intervention_name>
    <description>E1 is a dose level that has been investigated and well tolerated in the adult dose level groups C1 to C3. ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 10, 50, and 250 mg.</description>
    <arm_group_label>Part C (Elderly) E1, ACT-541478, fasted</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo</intervention_name>
    <description>Matching placebo will be provided in HPMC capsules for oral administration.</description>
    <arm_group_label>Part A (SAD) - A1, ACT-541478 10 mg fasted</arm_group_label>
    <arm_group_label>Part A (SAD) - A2, ACT-541478 30 mg fasted</arm_group_label>
    <arm_group_label>Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted</arm_group_label>
    <arm_group_label>Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed</arm_group_label>
    <arm_group_label>Part A (SAD) - A4, ACT-541478 300 mg fasted</arm_group_label>
    <arm_group_label>Part A (SAD) - A5, ACT-541478 1000 mg fasted</arm_group_label>
    <arm_group_label>Part B - B1-3, ACT-541478 low or high dose</arm_group_label>
    <arm_group_label>Part C (Elderly) E1, ACT-541478, fasted</arm_group_label>
    <arm_group_label>Part C (MAD) - C1, ACT-541478 30 mg, fasted</arm_group_label>
    <arm_group_label>Part C (MAD) - C2, ACT-541478 100 mg, fasted</arm_group_label>
    <arm_group_label>Part C (MAD) - C3, ACT-541478 300 mg, fasted</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part A/B/C:&#xD;
&#xD;
          -  Signed informed consent in a language understandable to the subject prior to any&#xD;
             study-mandated procedure.&#xD;
&#xD;
          -  BMI of 18.0 to 29.9 kg/m2 (inclusive) at Screening.&#xD;
&#xD;
          -  SBP 100-139 mmHg, DBP 50-89 mmHg, and pulse rate 50-90 bpm (inclusive), measured on&#xD;
             either arm, after 5 min in the supine position at Screening and on Day -1 in the first&#xD;
             period, if applicable.&#xD;
&#xD;
          -  Fertile male subjects (defined as physiologically capable of conceiving a child&#xD;
             according to the investigator's judgment) must agree to refrain from fathering a child&#xD;
             and:&#xD;
&#xD;
               1. be sexually abstinent with women of child-bearing potential or use condoms during&#xD;
                  sexual intercourse with women of child-bearing potential from (first) study&#xD;
                  treatment administration up to at least 90 days after (last) study treatment&#xD;
                  administration. Moreover, it is recommended that women of child-bearing potential&#xD;
                  partners of male subjects consistently and correctly use for the same period a&#xD;
                  highly effective method of contraception with a failure rate of &lt; 1% per year.&#xD;
&#xD;
               2. to not donate sperm from (first) study treatment administration up to at least 90&#xD;
                  days after (last) study treatment administration.&#xD;
&#xD;
          -  Body temperature in the range of 35.5° to 37.5 °C at Screening and on Day -1 in the&#xD;
             first period, if applicable.&#xD;
&#xD;
          -  12-lead safety ECG: QTcF ≤ 450 ms, QRS ≤ 110 ms, PR ≤ 220 ms, and resting HR 50-90 bpm&#xD;
             (inclusive) with no clinically relevant abnormalities on 12-lead safety ECG after at&#xD;
             least 5 min in the supine position at Screening and on Day -1 in the first period, if&#xD;
             applicable.&#xD;
&#xD;
          -  Normal renal function as confirmed by an estimated glomerular filtration rate ≥ 80&#xD;
             mL/min/1.73 m2 determined at Screening using the Chronic Kidney Disease Epidemiology&#xD;
             Collaboration formula.&#xD;
&#xD;
        Part A/B:&#xD;
&#xD;
        - Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.&#xD;
&#xD;
        Parts C1 to C3 (Adult subjects):&#xD;
&#xD;
        - Healthy male and female subjects aged between 18 and 55 years (inclusive) at Screening.&#xD;
&#xD;
        Parts E1 and E2 (Elderly subjects):&#xD;
&#xD;
        - Healthy male and female subjects aged between 65 and 80 years (inclusive) at Screening.&#xD;
&#xD;
        Parts C1 to C3, E1 and E2 (Female subjects):&#xD;
&#xD;
          -  Women of child-bearing potential must have a negative serum pregnancy test at&#xD;
             Screening and a negative urine pregnancy test on Day&#xD;
&#xD;
          -  1. They must consistently and correctly use (from Screening, during the entire study,&#xD;
             and for at least 30 days after last study treatment administration) a highly effective&#xD;
             method of contraception with a failure rate of &lt; 1% per year, or be sexually inactive,&#xD;
             or have a vasectomized partner. If a hormonal contraceptive is used, it must have been&#xD;
             initiated at least 1 month before first study treatment administration.&#xD;
&#xD;
          -  Women of child-bearing potential (i.e., postmenopausal [defined as 12 consecutive&#xD;
             months with no menses without an alternative medical cause, confirmed by an FSH test &gt;&#xD;
             40 mIU/mL], or with documented previous bilateral salpingectomy, bilateral salpingo&#xD;
             oophorectomy or hysterectomy, or with premature ovarian failure [confirmed by a&#xD;
             specialist], XY genotype, Turner syndrome, uterine agenesis).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Part A/B/C&#xD;
&#xD;
          -  History of major medical or surgical disorders, which, in the opinion of the&#xD;
             investigator, are likely to interfere with the absorption, distribution, metabolism,&#xD;
             or excretion of the study treatment (appendectomy and herniotomy allowed,&#xD;
             cholecystectomy not allowed).&#xD;
&#xD;
          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect&#xD;
             full participation in the study or compliance with the protocol.&#xD;
&#xD;
          -  History or presence of cardiac rhythm disorders (e.g., sinoatrial heart block,&#xD;
             sick-sinus syndrome, 2nd or 3rd degree AV block, long QT syndrome, symptomatic&#xD;
             bradycardia, atrial flutter, or atrial fibrillation).&#xD;
&#xD;
          -  Any illness with a potential to increase the risk of the subject based on medical&#xD;
             history.&#xD;
&#xD;
          -  Clinically relevant findings in clinical laboratory tests (hematology, clinical&#xD;
             chemistry, and urinalysis) at Screening (and on Day -1 in Part A and C) or any of the&#xD;
             following laboratory parameters out of normal range: ALT, AST, total bilirubin,&#xD;
             creatinine, TSH, and/or hemoglobin, at Screening and on Day -1 in the first period, if&#xD;
             applicable.&#xD;
&#xD;
          -  Any signs or symptoms of active, ongoing infection judged to be clinically relevant by&#xD;
             the investigator (special attention should be given to clinical signs and symptoms&#xD;
             consistent with COVID-19).&#xD;
&#xD;
        Part A (A3, effect of food)&#xD;
&#xD;
          -  Known lactose intolerance.&#xD;
&#xD;
          -  Known hereditary problems of galactose intolerance, Lapp lactase deficiency, or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          -  Inability or unwillingness to completely consume the required high-fat meal.&#xD;
&#xD;
        Part C&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Relevant history of a suicide attempt or suicidal behavior. Any recent suicidal&#xD;
             ideation within the last 6 months (categories 4 or 5), or any suicidal behavior within&#xD;
             the last 2 years, except for &quot;Non-Suicidal Self-Injurious Behavior&quot; (item also&#xD;
             included in the Suicidal Behavior section), as judged by the investigator using the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.&#xD;
&#xD;
          -  Result ≤ 27 in the Mini-Mental State Examination (MMSE®2™), assessed at Screening (E1&#xD;
             and E2 only).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Idorsia Pharmaceuticals Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Parexel International GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 6, 2021</last_update_submitted>
  <last_update_submitted_qc>July 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04452006
org study id: ID-088-101
nct id: NCT04452006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well
      as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid
      of of ACT-541478
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Part A: Single-ascending dose study in healthy male subjects (including investigation of the effect of food); Part B: Single-dose, three-way crossover study in healthy male subjects to investigate specific/additional parameters related to safety and tolerability; Part C: Multiple-ascending dose study in healthy male and female subjects (including healthy male and female elderly subjects).
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Treatment-emergent (serious) AEs
time frame: From (first) study treatment administration up to 96 h after last study treatment administration in the corresponding period (if applicable). Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): Cmax
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): tmax
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): AUC0-inf
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): t½
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): Cmax
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): tmax
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): AUCτ
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): t1/2
time frame: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.
measure: Specific/additional parameters related to safety and tolerability - Part B
time frame: At various timepoints. Total duration: up to 5 days.
arm group label: Part A (SAD) - A1, ACT-541478 10 mg fasted
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part A (SAD) - A2, ACT-541478 30 mg fasted
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part A (SAD) - A4, ACT-541478 300 mg fasted
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part A (SAD) - A5, ACT-541478 1000 mg fasted
arm group type: Experimental
description: SAD = single ascending dose
arm group label: Part B - B1-3, ACT-541478 low or high dose
arm group type: Experimental
arm group label: Part C (MAD) - C1, ACT-541478 30 mg, fasted
arm group type: Experimental
description: MAD = multiple ascending dose
arm group label: Part C (MAD) - C2, ACT-541478 100 mg, fasted
arm group type: Experimental
description: MAD = multiple ascending dose
arm group label: Part C (MAD) - C3, ACT-541478 300 mg, fasted
arm group type: Experimental
description: MAD = multiple ascending dose
arm group label: Part C (Elderly) E1, ACT-541478, fasted
arm group type: Experimental
intervention type: Drug
intervention name: ACT-541478 10 mg
description: ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.
arm group label: Part A (SAD) - A1, ACT-541478 10 mg fasted
intervention type: Drug
intervention name: ACT-541478 30 mg
description: ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.
arm group label: Part A (SAD) - A2, ACT-541478 30 mg fasted
arm group label: Part C (MAD) - C1, ACT-541478 30 mg, fasted
intervention type: Drug
intervention name: ACT-541478 100 mg
description: ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 50 mg.
arm group label: Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted
arm group label: Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed
arm group label: Part C (MAD) - C2, ACT-541478 100 mg, fasted
intervention type: Drug
intervention name: ACT-541478 300 mg
description: ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 50 mg and 250 mg.
arm group label: Part A (SAD) - A4, ACT-541478 300 mg fasted
arm group label: Part C (MAD) - C3, ACT-541478 300 mg, fasted
intervention type: Drug
intervention name: ACT-541478 1000 mg
description: ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 250 mg.
arm group label: Part A (SAD) - A5, ACT-541478 1000 mg fasted
intervention type: Drug
intervention name: ACT-541478 high or low dose (or placebo)
description: Cross-over design: ACT-541478 will be provided in HPMC capsules for oral administration at high or low dose strengths (to be defined after completion of Part A).
arm group label: Part B - B1-3, ACT-541478 low or high dose
intervention type: Drug
intervention name: ACT-541478 dose E1
description: E1 is a dose level that has been investigated and well tolerated in the adult dose level groups C1 to C3. ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 10, 50, and 250 mg.
arm group label: Part C (Elderly) E1, ACT-541478, fasted
intervention type: Drug
intervention name: Matching placebo
description: Matching placebo will be provided in HPMC capsules for oral administration.
arm group label: Part A (SAD) - A1, ACT-541478 10 mg fasted
arm group label: Part A (SAD) - A2, ACT-541478 30 mg fasted
arm group label: Part A (SAD) - A3 (Period 1), ACT-541478 100 mg fasted
arm group label: Part A (SAD) - A3 (Period 2), ACT-541478 100 mg fed
arm group label: Part A (SAD) - A4, ACT-541478 300 mg fasted
arm group label: Part A (SAD) - A5, ACT-541478 1000 mg fasted
arm group label: Part B - B1-3, ACT-541478 low or high dose
arm group label: Part C (Elderly) E1, ACT-541478, fasted
arm group label: Part C (MAD) - C1, ACT-541478 30 mg, fasted
arm group label: Part C (MAD) - C2, ACT-541478 100 mg, fasted
arm group label: Part C (MAD) - C3, ACT-541478 300 mg, fasted
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Idorsia Pharmaceuticals Ltd.
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No