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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 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 130 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03815695
The ClinicalTrials.gov registry entry for NCT03815695 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forma Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FT-4202/Placebo is the first listed.
NCT03815695 reports 0 study locations.
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.
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