Trials / Completed
CompletedNCT03114540
Single-Dose PK and Safety Study of GBT440 in Subjects With Hepatic Impairment
A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 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 (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
Detailed description
Approximately 24 to 28 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
- 2017-03-17
- Primary completion
- 2018-02-28
- Completion
- 2018-03-22
- First posted
- 2017-04-14
- Last updated
- 2023-07-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03114540. Inclusion in this directory is not an endorsement.