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NCT04971109 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
A Phase 3 study, sponsored by SIGA Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
NCT04971109: Completed Phase 3 study, sponsored by SIGA Technologies.
NCT04971109 is a Phase 3 study that has completed, run by SIGA Technologies. The registered enrollment target is 467 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04971109, a Phase 3 study, has completed, sponsored by SIGA Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
Study Summary
This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.
Primary Outcome
Cmin - Minimum TPOXX concentration in plasma
Interventions
- DRUG TPOXX
- OTHER TPOXX Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 3 |
What the finished NCT04971109 record still lists
NCT04971109 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which TPOXX is the first listed.
NCT04971109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04971109 about?
NCT04971109 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days". This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.
What is the current status of trial NCT04971109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2022-03-29. Estimated completion is 2023-05-12.
What interventions are being tested in trial NCT04971109?
The interventions under investigation include: TPOXX (DRUG), TPOXX Placebo (OTHER).
Who is sponsoring clinical trial NCT04971109?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04971109's enrollment target sits among peer trials
467 816th of 2000 higher than 1,185 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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