NCT01170975

Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2010-07-28
• Last updated: 2012-07-24

Locations

1 site across 1 country: United States