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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.

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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

FieldValue
Enrollment Target 130 participants
Start Date 2018-12-11
Est. Completion 2021-12-17
Phase Phase 1

Sponsor

Forma Therapeutics

8 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.