A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).

NCT00405080 | Completed Phase 1

• 1 other identifier: NKV105091
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Keywords

Rifampin GW679769

Outcome Measures

Primary Outcomes (1)

• Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.

  Up to Day 10

Secondary Outcomes (1)

• clinical lab tests adverse events vital signs 12 lead ECGs liver function tests

  Up to Day 12

Study Arms (2)

Treatment Period 1

EXPERIMENTAL

Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.

Drug: GW679769 (Casopitant) oral tablets

Treatment Period 2

EXPERIMENTAL

Subjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin.

Drug: GW679769 (Casopitant) oral tablets; Drug: Rifampin oral capsules

Interventions

GW679769 (Casopitant) oral tablets DRUG

Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.

Treatment Period 1; Treatment Period 2

Rifampin oral capsules DRUG

Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.

Also known as: GW679769 (Casopitant) oral tablets

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
• female subjects who cannot become pregnant
• able to swallow and keep down oral medication
• can understand and follow the protocol requirements and instructions

You may not qualify if:

• smokes at least 4 packs per day in the past 12 months
• use of prescription or non-prescription drug(s)
• herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
• a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
• blood donation in excess of 1 pint within 56 days before dosing of medication
• iron deficient
• history or drug allergy of study medication
• history of drug or alcohol abuse or dependency within the past 6 months
• subjects cannot use any nicotine-containing products within the last 6 months
• positive for HIV, Hepatitis B or C
• active peptic ulcer disease
• uncontrolled nausea and vomiting
• active infection
• heart failure
• female who is lactating

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tacoma, Washington, 98418, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study NKV105091 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

casopitant; Rifampin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic 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 29, 2006
• Study Start: November 11, 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)