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NCT03815695
A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
Phase 1 trial testing FT-4202/Placebo in Healthy Volunteers in 130 participants. Completed in 17 December 2021.
17 December 2021
Quick facts
| Lead sponsor | Forma Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 11 December 2018 |
| Primary completion | 17 December 2021 |
| Estimated completion | 17 December 2021 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- FT-4202/Placebo — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
Sponsor
Forma Therapeutics, Inc. — full company profile →
Who can join
Adults 12 to 65, any sex, with Healthy Volunteers or Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug Therapies for the Management of Sickle Cell Disease.
Rai P, Ataga KI. · · 2020 · cited 32× · PMID 32765834 · DOI 10.12688/f1000research.22433.1 -
FT-4202, an oral PKR activator, has potent antisickling effects and improves RBC survival and Hb levels in SCA mice.
Shrestha A, Chi M, Wagner K, Malik A, et al · · 2021 · cited 26× · PMID 33944896 · DOI 10.1182/bloodadvances.2020003604 -
Sickle cell disease: progress towards combination drug therapy.
Pace BS, Starlard-Davenport A, Kutlar A. · · 2021 · cited 24× · PMID 33471938 · DOI 10.1111/bjh.17312 -
Safety, Pharmacokinetics, and Pharmacodynamics of Etavopivat (FT-4202), an Allosteric Activator of Pyruvate Kinase-R, in Healthy Adults: A Randomized, Placebo-Controlled, Double-Blind, First-in-Human Phase 1 Trial.
Forsyth S, Schroeder P, Geib J, Vrishabhendra L, et al · · 2022 · cited 23× · PMID 35019238 · DOI 10.1002/cpdd.1058 -
Management of Sickle Cell Disease Complications Beyond Acute Chest Syndrome.
Ogu UO, Badamosi NU, Camacho PE, Freire AX, et al · · 2021 · cited 23× · PMID 33658881 · DOI 10.2147/jbm.s291394 -
Pyruvate Kinase Deficiency: Current Challenges and Future Prospects.
Fattizzo B, Cavallaro F, Marcello APML, Vercellati C, et al · · 2022 · cited 20× · PMID 36072510 · DOI 10.2147/jbm.s353907 -
Research in Sickle Cell Disease: From Bedside to Bench to Bedside.
Salinas Cisneros G, Thein SL. · · 2021 · cited 19× · PMID 34095767 · DOI 10.1097/hs9.0000000000000584 -
Fatty acid nitroalkenes - Multi-target agents for the treatment of sickle cell disease.
Chowdhury FA, Colussi N, Sharma M, Wood KC, et al · · 2023 · cited 12× · PMID 37907055 · DOI 10.1016/j.redox.2023.102941
Verify or expand the search:
- PubMed search for NCT03815695
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Forma Therapeutics, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03815695 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Forma Therapeutics, Inc.
- Last refreshed: 10 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03815695.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing