Trials / Completed
CompletedNCT02048787
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.
An Open-label, Single Dose, Multicenter Study to Evaluate the Pharmacokinetics and Safety of 50 mg Oral Buparlisib in Subjects With Moderate and Severe Renal Impairment Compared to Matched Control Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buparlisib | Subjects will receive a single dose of 50 mg buparlisib. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2014-01-29
- Last updated
- 2020-12-09
Locations
4 sites across 4 countries: Bulgaria, Czechia, Germany, Romania
Source: ClinicalTrials.gov record NCT02048787. Inclusion in this directory is not an endorsement.