Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules
Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT01170975
- Lead Sponsor
- Genta Incorporated
- Brief Summary
This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.
- Detailed Description
This study is being conducted to determine whether the pharmacokinetics of a single dose of tesetaxel administered as a capsule is affected by co-administration with food (a high-fat meal).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence 1 Tesetaxel 10 mg with and then without food Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state Treatment sequence 2 Tesetaxel 10 mg without and then with food Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters Predose and postdosing up to 36 days after administration of each dose Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)
- Secondary Outcome Measures
Name Time Method Safety and tolerability From screening through 36 days after administration of the final dose Adverse events, clinical laboratory tests, vital signs
Trial Locations
- Locations (1)
DaVita Clinical Researh
🇺🇸Minneapolis, Minnesota, United States