Conditions: Smallpox
Keywords: Treatment orthopoxvirus smallpox
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 449
Healthy volunteers: yes

Brief summary:
Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.

Detailed description:
Pharmacokinetics and safety and tolerability data will be collected.

Arms:
arm 1: 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects arm 2: matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects

Interventions: intervention 1: tecovirimat intervention 2: Placebo
Intervention descriptions: intervention 1: Study is based on Animal Regulatory Rule intervention 2: Does not apply

Protocol document: