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NCT03815695 · ClinicalTrials.gov registry record · Phase 1
A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
A Phase 1 study, sponsored by Forma Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
NCT03815695: Completed Phase 1 study, sponsored by Forma Therapeutics.
NCT03815695 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 130 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03815695, a Phase 1 study, has completed, sponsored by Forma Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
Study Summary
FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of FT-4202 in the context of Phase 1 studies in healthy volunteers and sickle cell disease patients. The effects of food on the absorption of FT-4202 will also be evaluated in healthy volunteers.
Interventions
- DRUG FT-4202/Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 1 |
What the finished NCT03815695 record still lists
NCT03815695 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 1 intervention - of which FT-4202/Placebo is the first listed.
NCT03815695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03815695 about?
NCT03815695 is a clinical study titled "A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients". FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple as...
What is the current status of trial NCT03815695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2018-12-11. Estimated completion is 2021-12-17.
What interventions are being tested in trial NCT03815695?
The interventions under investigation include: FT-4202/Placebo (DRUG).
Who is sponsoring clinical trial NCT03815695?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03815695's enrollment target sits among peer trials
130 439th of 2000 higher than 1,550 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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