Trials / Completed
CompletedNCT03161015
Single-Dose PK Study of GBT440 in Subjects With Renal Impairment
A Non-Randomized, Open-Label, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics of GBT440 in Subjects With Renal Impaired Function to Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Global Blood Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
Detailed description
Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GBT440 | Oral |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-05-25
- Completion
- 2017-07-06
- First posted
- 2017-05-19
- Last updated
- 2018-02-22
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03161015. Inclusion in this directory is not an endorsement.