<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/NCT04485039</url>
  </required_header>
  <id_info>
    <org_study_id>SIGA-246-023</org_study_id>
    <nct_id>NCT04485039</nct_id>
  </id_info>
  <brief_title>Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders</brief_title>
  <official_title>A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SIGA Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Advanced Research and Development Authority</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>PPD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SIGA Technologies</source>
  <oversight_info>
    <has_dmc>No</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>
      An open-label, drug-drug interaction study with TPOXX and phosphate binders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A postmarketing open-label, 5 period crossover, drug-drug interaction study of orally&#xD;
      administered TPOXX when coadministered with 4 different phosphate binders in healthy adult&#xD;
      subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2022</start_date>
  <completion_date type="Actual">April 23, 2023</completion_date>
  <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>5 period crossover</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>Measured from time 0 to 24 hours</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>Measured from time 0 to 48 hours</time_frame>
    <description>Area under the plasma concentration curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>Measured from time 0 to infinity</time_frame>
    <description>Area under the plasma concentration curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>Measured from time 0 to the last quantifiable concentration</time_frame>
    <description>Area under the plasma concentration curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>31 days</time_frame>
    <description>Maximum drug concentration in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma PK Parameter for TPOXX</measure>
    <time_frame>31 days</time_frame>
    <description>Time to maximum drug concentration in plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of 600 mg oral TPOXX administered with 4 different phosphate binders</measure>
    <time_frame>63 days</time_frame>
    <description>Monitoring and recording of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of 600 mg oral TPOXX administered with 4 different phosphate binders</measure>
    <time_frame>38 days</time_frame>
    <description>Laboratory testing: hematology, serum chemistry, pregnancy and urinalysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of 600 mg oral TPOXX administered with 4 different phosphate binders</measure>
    <time_frame>38 days</time_frame>
    <description>Vital Signs measurements including: systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of 600 mg oral TPOXX administered with 4 different phosphate binders</measure>
    <time_frame>38 days</time_frame>
    <description>12 lead ECG results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of 600 mg oral TPOXX administered with 4 different phosphate binders</measure>
    <time_frame>38 days</time_frame>
    <description>Physical Examinations</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Smallpox</condition>
  <arm_group>
    <arm_group_label>ABCDE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single oral dose of TPOXX 600 mg&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACEBD</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single oral dose of TPOXX 600 mg&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ADBEC</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single oral dose of TPOXX 600 mg&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate&#xD;
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet&#xD;
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AEDCB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single oral dose of TPOXX 600 mg&#xD;
Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.&#xD;
Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 1334 mg calcium acetate&#xD;
Single oral dose of TPOXX 600 mg coadministered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet&#xD;
Single oral dose of TPOXX 600 mg coadministered with single oral dose of 1600 mg sevelamer carbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPOXX</intervention_name>
    <description>oral antiviral and phosphate binders</description>
    <arm_group_label>ABCDE</arm_group_label>
    <arm_group_label>ACEBD</arm_group_label>
    <arm_group_label>ADBEC</arm_group_label>
    <arm_group_label>AEDCB</arm_group_label>
    <other_name>sevelamer carbonate oral tablet</other_name>
    <other_name>sucroferric oxyhydroxide chewable tablet</other_name>
    <other_name>calcium acetate oral tablet</other_name>
    <other_name>lanthanum carbonate chewable tablet</other_name>
    <other_name>TPOXX oral tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each subject must meet all of the following criteria to be enrolled in this study:&#xD;
&#xD;
               1. Subject is male or female 18 to 50 years of age, inclusive.&#xD;
&#xD;
               2. Phosphorus levels within normal laboratory reference range.&#xD;
&#xD;
               3. Women of childbearing potential have a negative human chorionic gonadotropin&#xD;
                  pregnancy test (serum) at the screening visit and a confirmatory negative serum&#xD;
                  pregnancy test on Day -1 of each period before receipt of study drug, and meet&#xD;
                  one of the following criteria:&#xD;
&#xD;
                    1. The subject or their partner has undergone surgical sterilization&#xD;
&#xD;
                    2. The subject is postmenopausal, defined as 12 consecutive months with no&#xD;
                       menses without an alternative medical cause and has a documented plasma&#xD;
                       follicle-stimulating hormone level &gt;40 IU/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant&#xD;
             within 3 months after the last dose of study drug.&#xD;
&#xD;
          2. Subject has a history of any clinically significant conditions including:&#xD;
&#xD;
               -  Asthma treated with oral systemic steroids within the past 6 months&#xD;
&#xD;
               -  Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes&#xD;
&#xD;
               -  Hypertension that is poorly controlled (repeat readings &gt;140 mm Hg systolic&#xD;
                  and/or &gt;90 mm Hg diastolic)&#xD;
&#xD;
               -  Thyroidectomy or thyroid disease that required medication within the past 12&#xD;
                  months&#xD;
&#xD;
               -  Serious angioedema episodes within the previous 3 years or requiring medication&#xD;
                  in the previous 2 years&#xD;
&#xD;
               -  Head trauma resulting in a diagnosis of traumatic brain injury other than&#xD;
                  concussion&#xD;
&#xD;
               -  Frequent episodes of headache.&#xD;
&#xD;
          3. Subject has received treatment in another clinical study of an investigational drug&#xD;
             (or medical device) within 30 days or 5 half-lives (whichever is longer) before the&#xD;
             first dose of study drug.&#xD;
&#xD;
          4. Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or&#xD;
             excipients, or any significant food allergy that could preclude a standard diet in the&#xD;
             study site).&#xD;
&#xD;
          5. Subject has any condition possibly affecting drug absorption (eg, previous surgery on&#xD;
             the gastrointestinal tract, including removal of parts of the stomach, bowel, liver,&#xD;
             gallbladder, or pancreas, with the exception of appendectomy).&#xD;
&#xD;
          6. Subject has evidence or history of clinically significant allergic (except for&#xD;
             untreated, asymptomatic, seasonal allergies at time of the first dose of study drug),&#xD;
             hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,&#xD;
             psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild&#xD;
             joint disease unassociated with collagen vascular disease) may be made following&#xD;
             discussions with the medical monitor.&#xD;
&#xD;
          7. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias,&#xD;
             syncopal episodes, or risk factors for torsades de pointes (eg, heart failure,&#xD;
             hypokalemia).&#xD;
&#xD;
          8. Subject has a family history of sudden cardiac death not clearly due to acute&#xD;
             myocardial infarction.&#xD;
&#xD;
          9. Subject has a seizure disorder or history of seizures (does not include childhood&#xD;
             febrile seizures) or a past history that increases seizure risks such as significant&#xD;
             head injury that caused loss of consciousness or other changes in the subject's daily&#xD;
             function, concussion, stroke, central nervous system infection or disease, or alcohol&#xD;
             or drug abuse or family history of idiopathic seizures.&#xD;
&#xD;
         10. Subject has a history of a peptic ulcer or significant gastrointestinal bleeding.&#xD;
&#xD;
         11. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency,&#xD;
             coagulopathy, or platelet disorder requiring special precautions) or significant&#xD;
             bruising or bleeding difficulties with blood draws.&#xD;
&#xD;
         12. Subject has a malignancy that is active, or treated malignancy for which there is not&#xD;
             reasonable assurance of sustained cure, or malignancy that is likely to recur during&#xD;
             the period of the study (subject should be in complete remission for at least 5&#xD;
             years).&#xD;
&#xD;
         13. Subject has neutropenia or other blood dyscrasia determined to be clinically&#xD;
             significant by the investigator.&#xD;
&#xD;
         14. Subject has used any of the following prohibited medications from within 7 days (or 5&#xD;
             half lives, whichever is longer) before the first dose of study drug: antidiabetic&#xD;
             medication; anticoagulants; anticonvulsants; substrates of the breast cancer&#xD;
             resistance protein transporter including methotrexate, mitoxantrone, imatinib,&#xD;
             irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of&#xD;
             CYP2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone;&#xD;
             and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole,&#xD;
             voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known&#xD;
             (or thought) to be CYP3A4 substrates may be allowed at the investigator's discretion,&#xD;
             after consultation with the medical monitor, if administration poses little to no risk&#xD;
             to the subject.&#xD;
&#xD;
         15. Subject has a history of drug or alcohol abuse or dependency within the last year&#xD;
             before screening.&#xD;
&#xD;
         16. Subject has a current or recent (&lt;30 days before screening) history of clinically&#xD;
             significant bacterial, fungal, or mycobacterial infection.&#xD;
&#xD;
         17. Subject has a current clinically significant viral infection.&#xD;
&#xD;
         18. Subject has a known clinically significant chronic viral infection (eg, human T cell&#xD;
             lymphotropic virus I or II).&#xD;
&#xD;
         19. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange&#xD;
             containing products (eg, marmalade), or caffeine- or xanthine containing products&#xD;
             within 48 hours before the first dose of study drug.&#xD;
&#xD;
         20. Subject has used any prescription (excluding hormonal birth control) or over the&#xD;
             counter medication (including herbal or nutritional supplements) within 14 days before&#xD;
             the first dose of study drug.&#xD;
&#xD;
         21. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including&#xD;
             oral or parenteral prednisone or equivalent (&gt;20 mg total dose per day) or high-dose&#xD;
             inhaled steroids (&gt;800 mcg/day of beclomethasone dipropionate or equivalent) within&#xD;
             the preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or&#xD;
             equivalent] inhaled and topical steroids are allowed).&#xD;
&#xD;
         22. Subject has donated &gt;450 mL blood or blood components within 30 days before the first&#xD;
             dose of study drug. The investigator should instruct subjects who participate in this&#xD;
             study to not donate blood or blood components for 4 weeks after the completion of the&#xD;
             study.&#xD;
&#xD;
         23. Subject is a smoker or has used nicotine or nicotine containing products (eg,&#xD;
             cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine&#xD;
             patches, or nicotine gum) within 6 months before the first dose of study drug.&#xD;
&#xD;
         24. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice,&#xD;
             or alcohol within 72 hours before the first dose of study drug.&#xD;
&#xD;
         25. Subject reports participation in strenuous activity or contact sports within 24 hours&#xD;
             before the first dose of study drug.&#xD;
&#xD;
         26. Subject has known hepatitis B or C infection or positive test for hepatitis B surface&#xD;
             antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2&#xD;
             antibodies at screening.&#xD;
&#xD;
         27. Subject has a positive test result for amphetamines (including methamphetamines and&#xD;
             ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids&#xD;
             (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin,&#xD;
             codeine, and oxycodone), or alcohol at screening or check-in.&#xD;
&#xD;
         28. Subject has any of the following laboratory test results within 28 days before the&#xD;
             first dose of study drug:&#xD;
&#xD;
               -  Estimated serum creatinine clearance (Cockcroft-Gault) &lt;70 mL/min&#xD;
&#xD;
               -  Creatinine in males &gt;1.7 mg/dL and in females &gt;1.4 mg/dL (1.3 times the upper&#xD;
                  laboratory reference range)&#xD;
&#xD;
               -  Hemoglobin ≤10% of the lower laboratory reference range&#xD;
&#xD;
               -  White blood cell count considered to be clinically significant by the&#xD;
                  investigator&#xD;
&#xD;
               -  Absolute neutrophil count &lt;1000 cells/mm3&#xD;
&#xD;
               -  Platelets not within ±10% of laboratory reference range&#xD;
&#xD;
               -  Alanine aminotransferase &gt;2.0 times above the upper laboratory reference range&#xD;
&#xD;
               -  Aspartate aminotransferase &gt;2.0 times above the upper laboratory reference range&#xD;
&#xD;
               -  Alkaline phosphatase &gt;20% above the upper laboratory reference range&#xD;
&#xD;
               -  Hemoglobin A1c ≥7.0%&#xD;
&#xD;
               -  Cholesterol ≥300 mg/dL and low density lipoprotein ≥190 mg/dL.&#xD;
&#xD;
         29. Subject has a blood pressure considered to be clinically significant by the&#xD;
             investigator. Blood pressure may be retested twice in the sitting position at 5 minute&#xD;
             intervals.&#xD;
&#xD;
         30. Subject has a resting heart rate of &lt;40 beats per minute or &gt;110 beats per minute at&#xD;
             screening.&#xD;
&#xD;
         31. Subject has an abnormal ECG at screening that is determined by the investigator to be&#xD;
             clinically significant.&#xD;
&#xD;
         32. Male subject has a QT interval corrected using Fridericia's formula (QTcF) &gt;450 ms or&#xD;
             female subject has a QTcF &gt;470 ms at screening or Day -1.&#xD;
&#xD;
         33. In the opinion of the investigator, the subject is not suitable for entry into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Hruby, PhD</last_name>
    <role>Study Director</role>
    <affiliation>SIGA Technologies Chief Scientific Officer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPD Phase I Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Smallpox</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tecovirimat</mesh_term>
    <mesh_term>Sevelamer</mesh_term>
    <mesh_term>Calcium acetate</mesh_term>
  </intervention_browse>
  <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/NCT04485039
org study id: SIGA-246-023
nct id: NCT04485039
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
An open-label, drug-drug interaction study with TPOXX and phosphate binders.
A postmarketing open-label, 5 period crossover, drug-drug interaction study of orally
      administered TPOXX when coadministered with 4 different phosphate binders in healthy adult
      subjects.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 5 period crossover
primary purpose: Other
masking: None (Open Label)
measure: Plasma PK Parameter for TPOXX
time frame: Measured from time 0 to 24 hours
description: Area under the plasma concentration versus time curve (AUC)
measure: Plasma PK Parameter for TPOXX
time frame: Measured from time 0 to 48 hours
description: Area under the plasma concentration curve (AUC)
measure: Plasma PK Parameter for TPOXX
time frame: Measured from time 0 to infinity
description: Area under the plasma concentration curve (AUC)
measure: Plasma PK Parameter for TPOXX
time frame: Measured from time 0 to the last quantifiable concentration
description: Area under the plasma concentration curve (AUC)
measure: Plasma PK Parameter for TPOXX
time frame: 31 days
description: Maximum drug concentration in plasma
measure: Plasma PK Parameter for TPOXX
time frame: 31 days
description: Time to maximum drug concentration in plasma
measure: Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
time frame: 63 days
description: Monitoring and recording of adverse events
measure: Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
time frame: 38 days
description: Laboratory testing: hematology, serum chemistry, pregnancy and urinalysis
measure: Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
time frame: 38 days
description: Vital Signs measurements including: systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature
measure: Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
time frame: 38 days
description: 12 lead ECG results
measure: Safety of 600 mg oral TPOXX administered with 4 different phosphate binders
time frame: 38 days
description: Physical Examinations
arm group label: ABCDE
arm group type: Other
description: Single oral dose of TPOXX 600 mg
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
arm group label: ACEBD
arm group type: Other
description: Single oral dose of TPOXX 600 mg
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate
arm group label: ADBEC
arm group type: Other
description: Single oral dose of TPOXX 600 mg
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 1334 mg calcium acetate
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 1600 mg sevelamer carbonate
Single oral dose of TPOXX 600 mg co-administered with a single oral dose of 500 mg lanthanum carbonate chewable tablet
Single oral dose of TPOXX 600 mg co-administered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
arm group label: AEDCB
arm group type: Other
description: Single oral dose of TPOXX 600 mg
Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 500 mg lanthanum carbonate chewable tablet.
Single oral dose of TPOXX 600 mg coadministered with a single oral dose of 1334 mg calcium acetate
Single oral dose of TPOXX 600 mg coadministered with single oral dose of 500 mg sucroferric oxyhydroxide chewable tablet
Single oral dose of TPOXX 600 mg coadministered with single oral dose of 1600 mg sevelamer carbonate
intervention type: Drug
intervention name: TPOXX
description: oral antiviral and phosphate binders
arm group label: ABCDE
arm group label: ACEBD
arm group label: ADBEC
arm group label: AEDCB
other name: sevelamer carbonate oral tablet
other name: sucroferric oxyhydroxide chewable tablet
other name: calcium acetate oral tablet
other name: lanthanum carbonate chewable tablet
other name: TPOXX oral tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis Hruby, PhD
role: Study Director
affiliation: SIGA Technologies Chief Scientific Officer
facility: 
country: United States
responsible party type: Sponsor
mesh term: Smallpox
mesh term: Tecovirimat
mesh term: Sevelamer
mesh term: Calcium acetate
sharing ipd: No