CompletedPhase 4

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

United States44 participantsStarted 2022-06-08

Plain-language summary

An open-label, drug-drug interaction study with TPOXX and phosphate binders.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Subject is male or female 18 to 50 years of age, inclusive.
✓. Phosphorus levels within normal laboratory reference range.
✓. Women of childbearing potential have a negative human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 of each period before receipt of study drug, and meet one of the following criteria:
✓. The subject or their partner has undergone surgical sterilization
✓. The subject is postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level \>40 IU/mL

Exclusion criteria

✕. Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.
✕. Subject has a history of any clinically significant conditions including:
✕. Subject has received treatment in another clinical study of an investigational drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
✕. Subject has a history of relevant drug and/or food allergies (ie, allergy to TPOXX or excipients, or any significant food allergy that could preclude a standard diet in the study site).
✕. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).
✕. Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.
✕. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
✕. Subject has a family history of sudden cardiac death not clearly due to acute myocardial infarction.

What they're measuring

AUC0-inf

Timeframe: Day 3

Cmax

Timeframe: Day 3

Trial details

NCT IDNCT04485039

SponsorSIGA Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-15

Results submitted2024-08-15

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