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A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

NCT00460707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-08-03

No results posted yet for this study

Summary

Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.

Conditions

  • Nausea and Vomiting, Chemotherapy-Induced

Interventions

DRUG

Casopitant 150 mg

Casopitant 150 mg will be available as white, film-coated tablets. Casopitant tablets will be taken with 240 milliliters (mL) of water at room temperature on an empty stomach.

DRUG

Ketoconazole

Ketoconazole will be available as 200 mg tablets which will be taken with 240 mL of water on an empty stomach (after a 2 hour fast on Day 4 of Treatment Period 2 and after a 1 hour fast on all other dosing days).

DRUG

Casopitant 150 mg matching placebo

Casopitant 150 mg matching placebo will be available as white, film-coated tablets.

DRUG

Casopitant 50 mg

Casopitant 50 mg will be available as pale orange, film-coated tablets. Casopitant tablets will be taken with 240 mL of water at room temperature on an empty stomach.

DRUG

Casopitant 50 mg matching placebo

Casopitant 50 mg matching placebo will be available as pale orange, film-coated tablets.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-16
Primary Completion
2007-08-27
Completion
2007-08-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00460707 on ClinicalTrials.gov