Trials / Completed
CompletedNCT01324310
Influence of Ketoconazole 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 Ketoconazole on the Single Dose Pharmacokinetics of Romidepsin in Subjects With Advanced Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (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 ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romidepsin | Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8. |
| DRUG | Ketoconazole | Ketoconazole 400 mg oral once daily on Days 4-8 |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2011-03-29
- Last updated
- 2019-11-25
- Results posted
- 2013-05-15
Locations
3 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01324310. Inclusion in this directory is not an endorsement.