A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment
Latest Information Update: 21 Oct 2024
At a glance
- Drugs Osivelotor (Primary)
- Indications Sickle cell anaemia
- Focus Pharmacokinetics
- Sponsors Global Blood Therapeutics; Pfizer
Most Recent Events
- 12 Sep 2024 Status changed from recruiting to discontinued.Reason the study was stopped: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.
- 20 Mar 2024 Planned number of patients changed from 56 to 40.
- 20 Mar 2024 Planned End Date changed from 9 Jul 2024 to 4 Oct 2024.