Trials / Completed
CompletedNCT01324323
Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer
A Phase I Open-label, 2-period Study to Evaluate the Influence of Multiple Oral Doses of Rifampin on the Single Dose Pharmacokinetics of Romidepsin in Subjects With Advanced Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romidepsin | 14 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8. |
| DRUG | Rifampin | 600 mg oral once daily on Days 4-8 |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2012-02-01
- Completion
- 2012-03-01
- First posted
- 2011-03-29
- Last updated
- 2019-11-25
- Results posted
- 2013-05-13
Locations
3 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01324323. Inclusion in this directory is not an endorsement.