Conditions: Hematologic Malignancy Malignant Lymphoma
Keywords: ROMI-001 romi Romidepsin Istodax advanced malignancy PK pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.

Ketoconazole 400 mg oral once daily on Days 4-8

Interventions: intervention 1: Romidepsin intervention 2: Ketoconazole
Intervention descriptions: intervention 1: Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8. intervention 2: Ketoconazole 400 mg oral once daily on Days 4-8

Protocol document: