Trials / Completed
CompletedNCT01904214
A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAF312 | Treatment with a single oral dose of 0.25 mg BAF312 |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2013-07-22
- Last updated
- 2020-12-08
Locations
2 sites across 2 countries: United States, Romania
Source: ClinicalTrials.gov record NCT01904214. Inclusion in this directory is not an endorsement.