Trials / Completed
CompletedNCT05718687
A GBT021601 ADME Microtracer Study in Healthy Volunteers
A PHASE 1 STUDY TO ASSESS THE MASS BALANCE, EXCRETION, AND PHARMACOKINETICS OF [14C]-GBT021601, AN ORAL HEMOGLOBIN SPOLYMERIZATION INHIBITOR, IN HEALTHY PARTICIPANTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
An Open-label Study of GBT021601 in 8 to 10 healthy male or female participants to evaluate the absorption, distribution, metabolism, and excretion (ADME) of GBT021601.
Detailed description
This is an open-label Study administering GBT021601 as a single oral dose of 200 mg in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GBT021601 | Single oral dose of 200 mg GBT021601, containing \~74 kBq (\~2 µCi) of \[14C\]-GBT021601 |
Timeline
- Start date
- 2022-12-22
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
- First posted
- 2023-02-08
- Last updated
- 2025-01-08
- Results posted
- 2025-01-08
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05718687. Inclusion in this directory is not an endorsement.