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

NCT00404378 | Completed Phase 1

• 1 other identifier: NKV105093
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy subjects; Pharmacokinetics; Drug interaction; Ketoconazole; Casopitant

Outcome Measures

Primary Outcomes (2)

• Plasma levels will be measured for casopitant at Period 1: Day 1, 2 & 3.

  Period 1: Day 1, 2 & 3

• Plasma levels will be measured for casopitant and ketoconazole at Period 2: Day 4, 5, 6, 7, & 8.

  Period 2: Day 4, 5, 6, 7, & 8.

Secondary Outcomes (1)

• clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests

  throughout the study

Study Arms (4)

Cohort 1 Treatment Period 1

EXPERIMENTAL

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

Drug: casopitant 100 mg

Cohort 1 Treatment Period 2

EXPERIMENTAL

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.

Drug: ketoconazole; Drug: casopitant 100 mg

Cohort 2 Treatment Period 1

EXPERIMENTAL

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

Drug: Casopitant 50 mg

Cohort 2 Treatment Period 2

EXPERIMENTAL

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.

Drug: ketoconazole; Drug: Casopitant 50 mg

Interventions

ketoconazole 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.

Cohort 1 Treatment Period 2; Cohort 2 Treatment Period 2

casopitant 100 mg 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

Also known as: casopitant, ketoconazole

Cohort 1 Treatment Period 1; Cohort 1 Treatment Period 2

Casopitant 50 mg 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 1; Cohort 2 Treatment Period 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

Related Links

• Results for study NKV105093 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ketoconazole; casopitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: October 20, 2006
• Primary Completion: January 5, 2007
• Study Completion: January 5, 2007
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)