At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
GBT021601drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Intrapatient Single Dose and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of GBT021601, a Hemoglobin S Polymerization Inhibitor, in Participants With Sickle Cell Disease (SCD)
In Brief
A Phase 1 clinical trial evaluating GBT021601 for Sickle Cell Disease. Completed, enrolled 6 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK), and pharmacodynamics (i.e., how the body absorbs, distributes, breaks down, and excretes) of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in participants with SCD, following single and multiple ascending doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMay 2021
First PostedJul 2021
Primary CompletionDec 2022
TodayJul 2026
First PostedJul 30, 2021
Enrollment StartMay 21, 2021
Primary CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago
Interventions
GBT021601drug
Tablets and capsules which contain GBT021601 drug substance