Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

NCT01170975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-07-24

No results posted yet for this study

Summary

This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.

Conditions

Interventions

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

Sponsors & Collaborators

  • Genta Incorporated

    lead INDUSTRY

Principal Investigators

  • Harry W Alcorn, PharmD · Davita Clinical Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-02-28
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170975 on ClinicalTrials.gov