Trials / Completed
CompletedNCT02624557
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
A Phase 1, Open-label, Single-dose, Multicenter, Parallel Group Study to Assess the Pharmacokinetics and Safety of Alpelisib (BYL719) in Subjects With Hepatic Impairment Compared to Matched Healthy Control Subjects.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alpelisib | Subjects will receive a single dose of 300 mg alpelisib. |
Timeline
- Start date
- 2015-12-21
- Primary completion
- 2017-10-01
- Completion
- 2017-10-01
- First posted
- 2015-12-08
- Last updated
- 2020-12-09
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02624557. Inclusion in this directory is not an endorsement.