Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
NCT04485039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-12-27
Summary
An open-label, drug-drug interaction study with TPOXX and phosphate binders.
Conditions
Interventions
- DRUG
-
Tecovirimat
oral antiviral
- DRUG
-
sevelamer carbonate oral tablet
phosphate binder
- DRUG
-
sucroferric oxyhydroxide chewable tablet
phosphate binder
- DRUG
-
calcium acetate oral tablet
phosphate binder
- DRUG
-
Lanthanum Carbonate Chewable Tablet
phosphate binder
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
PPD Development, LP
collaborator INDUSTRY -
SIGA Technologies
lead INDUSTRY
Principal Investigators
-
Dennis Hruby, PhD · SIGA Technologies Chief Scientific Officer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-08
- Primary Completion
- 2022-12-15
- Completion
- 2023-04-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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