Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769]

NCT ID: NCT00404378

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-20
• Study Completion Date: 2007-01-05

Brief Summary

This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 Treatment Period 1

Subjects will receive single oral dose of 100 milligram (mg) of Casopitant. There will be wash out period of 7 days.

Group Type: EXPERIMENTAL

casopitant 100 mg

Intervention Type: DRUG

Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time

Cohort 1 Treatment Period 2

Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 100 mg along with ketoconazole.

Group Type: EXPERIMENTAL

ketoconazole

Intervention Type: DRUG

Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

casopitant 100 mg

Intervention Type: DRUG

Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time

Cohort 2 Treatment Period 1

Subjects will receive single oral dose of 50 mg of Casopitant. There will be wash out period of 7 days.

Group Type: EXPERIMENTAL

Casopitant 50 mg

Intervention Type: DRUG

Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Cohort 2 Treatment Period 2

Subjects will receive ketoconazole 400 mg once daily on Days 1 - 7. On Day 4 subjects will receive a single dose of oral casopitant 50 mg along with ketoconazole.

Group Type: EXPERIMENTAL

ketoconazole

Intervention Type: DRUG

Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Casopitant 50 mg

Intervention Type: DRUG

Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Interventions

ketoconazole

Ketoconazole tablets will be available with dose strength of 200 mg. The dose of ketoconazole 400 mg will be comprised of two 200 mg tablets. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Intervention Type: DRUG

casopitant 100 mg

Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive two 50 mg tablets for the dose of 100 mg. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time

Intervention Type: DRUG

Casopitant 50 mg

Casopitant tablets will be available with dose strength of 50 mg and will receive single dose. On Day 4 of Treatment Period 2, the dose of casopitant and ketoconazole is to be taken at the same time.

Intervention Type: DRUG

Other Intervention Names

casopitant; ketoconazole

Eligibility Criteria

Inclusion Criteria

• Healthy male or females
• Females must be of non-childbearing potential
• Adequate organ functions
• Able to swallow and retain oral medications
• Able to understand and comply with study requirements
• Signed ICF

Exclusion Criteria

• Clinically relevant abnormality identified on the screening exam or any other medical condition or circumstance making the subject unsuitable for participation in the study.
• History of drug or other allergy which contraindicates participation.
• Known immediate hypersensitivity reaction or idiosyncrasy to GW679769 or ketoconazole or drugs chemically related to the study medications.
• Use of an investigational drug within 28 days preceding the first dose of GW679769 or ketoconazole or participation in another clinical trial within the past 30 days.
• Blood donation in excess of 1 pint within 56 days prior to first dose of study medication or intends to donate within 30 days of the post-treatment follow-up visit.
• History of or suspected iron deficiency.
• Positive stool for occult blood.
• Pepsinogen level below the lower limit of laboratory reference range (LLRR).
• Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test.
• For male subjects, any history of hypogonadism and treatments associated with hypogonadism including radiation therapy to the testicles.
• For female subjects, a positive serum ß-hCG (beta-human chorionic gonadotropin) pregnancy test.
• Female subject who is lactating.
• Positive urine drug screen (UDS) including alcohol.
• Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
• Positive urinary cotinine. Subjects must not have used any nicotine-containing products, including nicotine patches or gum, within the past 6 months.
• Smoking history = 4 packs per day/year or smoked within the past 12 months.
• History of drug abuse or dependence within the past 6 months.
• History of alcohol abuse within the past 6 months or alcohol consumption in the past 6 months exceeding study requirements
• Presence of uncontrolled nausea & vomiting.
• Presence of an active infection.
• Any degree of heart failure as defined by the New York Heart Association functional classification system.
• Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
• Use of any prescription or non-prescription drug(s), herbal or dietary supplements or vitamins within 14 days prior to the first dose of study medication.
• Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pomelos or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi and brussels sprouts, mustard) within 14 days prior to the first dose of study medication.
• History of cholecystectomy or biliary tract disease.
• Any serious or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study.

• 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

Lenexa, Kansas, United States

Countries

United States

Study Documents

Document Type: Dataset Specification

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

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Document Type: Annotated Case Report Form

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

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Document Type: Study Protocol

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

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Document Type: Individual Participant Data Set

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

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Document Type: Clinical Study Report

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

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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

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

NKV105093

Identifier Type: -

Identifier Source: org_study_id