Trials / Completed
CompletedNCT04276662
Study of Single-dose DS-3201b in Participants With Hepatic Impairment
An Open-label, Single-dose Study to Assess the Pharmacokinetics of DS-3201b In Subjects With Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-3201b | 1 dose of 50 mg DS-3201b |
Timeline
- Start date
- 2019-11-21
- Primary completion
- 2021-02-23
- Completion
- 2021-02-23
- First posted
- 2020-02-19
- Last updated
- 2021-02-25
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04276662. Inclusion in this directory is not an endorsement.