Trials / Terminated
TerminatedNCT02873650
Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment
A Phase I, Open Label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics of Dabrafenib in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dabrafenib | Single dose of 100 mg dabrafenib on Day 1 |
Timeline
- Start date
- 2016-12-20
- Primary completion
- 2018-10-12
- Completion
- 2019-04-08
- First posted
- 2016-08-19
- Last updated
- 2020-12-08
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02873650. Inclusion in this directory is not an endorsement.