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

NCT ID: NCT00460707

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-16
• Study Completion Date: 2007-08-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT

Study Groups

Cohort 1

All subjects in Cohort 1 will receive ketoconazole 400 milligrams (mg) once daily on Day 1 to 9 and oral casopitant 150 mg on Day 4 and 50 mg on Day 5 and Day 6 of treatment period 1. After a washout period of 21 days, subjects will be administered oral casopitant 150 mg on Day 1 and 50 mg on Day 2 and Day 3 of treatment period 2.

Group Type: EXPERIMENTAL

Casopitant 150 mg

Intervention Type: DRUG

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.

Ketoconazole

Intervention Type: DRUG

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).

Casopitant 50 mg

Intervention Type: DRUG

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.

Cohort 2, Group A

Subjects will receive placebo once daily on Day 1 to Day 3 in treatment period 1. Subjects will receive ketoconazole 400 mg once daily on Day 1 to Day 9 and oral placebo once daily on Days 4, 5 and 6 in treatment period 2. There will be a 14-day washout period between treatment periods 1 and 2.

Group Type: PLACEBO_COMPARATOR

Ketoconazole

Intervention Type: DRUG

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).

Casopitant 150 mg matching placebo

Intervention Type: DRUG

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

Casopitant 50 mg matching placebo

Intervention Type: DRUG

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

Cohort 2, Group B

In treatment period 1, subjects will receive oral casopitant 150 mg on Day 1 and 50 mg on Days 2 and 3. In treatment period 2, they will be administered ketoconazole 400 mg once daily on Day 1 to Day 9 and oral casopitant 150 mg on Day 4 and 50 mg on Days 5 and 6. There will be a 14-day washout period between treatment periods 1 and 2.

Group Type: EXPERIMENTAL

Casopitant 150 mg

Intervention Type: DRUG

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.

Ketoconazole

Intervention Type: DRUG

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).

Casopitant 50 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Casopitant 150 mg matching placebo

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

Intervention Type: 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.

Intervention Type: DRUG

Casopitant 50 mg matching placebo

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

Intervention Type: DRUG

Other Intervention Names

Casopitant

Eligibility Criteria

Inclusion Criteria

• A female subject who is non-childbearing potential or using acceptable contraceptive methods.
• Adequate organ system functions.
• Able to swallow and retain oral medication.
• Subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study.

Exclusion Criteria

• Current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor.
• History of drug or other allergy which, in the opinion of the study doctor, contraindicates participation.
• Use of an investigational drug within 28 days or 5 half-lives.
• Use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication.
• Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
• Iron deficiency.
• Positive stool for occult blood.
• Female subject who is pregnant or lactating.
• Male subject who has a history of hypogonadism.
• Positive urine drug screen.
• Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen.
• Use of tobacco-containing products within the past 12 months prior to screening.
• History of drug or alcohol abuse or dependence within 6 months of screening.
• History or presence of uncontrolled emesis.
• Presence of active infection.
• History of cholecystectomy or biliary tract disease.
• Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
• Any degree of heart failure.
• Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pommelos or vegetables from the mustard green family within 7 days prior to the first dose unless prior approval is received.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Buffalo, New York, United States

GSK Investigational Site

Columbus, Ohio, United States

Countries

United States

References

Johnson BM, Adams LM, Zhang K, Gainer SD, Kirby LC, Blum RA, Apseloff G, Morrison RA, Schutz RA, Lebowitz PF. Ketoconazole and rifampin significantly affect the pharmacokinetics, but not the safety or QTc interval, of casopitant, a neurokinin-1 receptor antagonist. J Clin Pharmacol. 2010 Aug;50(8):951-9. doi: 10.1177/0091270009353761. Epub 2010 Feb 2.

Reference Type: BACKGROUND

PMID: 20124517 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

NKV109990

Identifier Type: -

Identifier Source: org_study_id