A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers, Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT03815695
- Run by
- Forma Therapeutics, Inc.
- People needed
- 130
- Starts
- 2018-12-11
- Expected to finish
- 2021-12-17
- Last updated by the study team
- 2024-04-10
Who can join
Age: 12 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Woodland International Research Group (SCD subjects only) — Little Rock, Arkansas, United States
- Collaborative Neuroscience Research, LLC (SCD subjects only) — Long Beach, California, United States
- Pacific Research Partners (SCD subjects only) — Oakland, California, United States
- UCSF Benioff Children's Hospital Oakland (SCD subjects only) — Oakland, California, United States
- Advanced Pharma CR, LLC (SCD subjects only) — Miami, Florida, United States
- Children's Healthcare of Atlanta (SCD subjects only) — Atlanta, Georgia, United States
- Augusta University Medical Center (SCD subjects only) — Augusta, Georgia, United States
- University of Illinois at Chicago (SCD subjects only) — Chicago, Illinois, United States
- University of Maryland, Greenebaum Comprehensive Cancer Center (SCD subjects only) — Baltimore, Maryland, United States
- Columbia University Medical Center (SCD subjects only) — New York, New York, United States
- Levine Cancer Institute (SCD subjects only) — Charlotte, North Carolina, United States
- Duke University Medical Center (SCD subjects only) — Durham, North Carolina, United States
- University of Cincinnati Medical Center (SCD subjects only) — Cincinnati, Ohio, United States
- Medpace Clinical Pharmacology Unit (Healthy Volunteers only) — Cincinnati, Ohio, United States
- Cincinnati Children's Hospital Medical Center (SCD subjects only) — Cincinnati, Ohio, United States
- Lynn Institute of Tulsa (SCD subjects only) — Tulsa, Oklahoma, United States
- St. Jude Children's Research Hospital (SCD subjects only) — Memphis, Tennessee, United States
- The University of Texas Health Science Center at Houston (SCD subjects only) — Houston, Texas, United States
Full record on ClinicalTrials.gov
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