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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00405080

Purpose

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

Condition	Intervention	Phase
Emesis	Drug: GW679769 (Casopitant) oral tablets Drug: Rifampin oral tablets	Phase I

Drug Information available for: Rifampin GW679769

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Estimated Enrollment:	12
Study Start Date:	November 2006

Eligibility

Criteria

Inclusion criteria:

Exclusion criteria:

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
female who has a positive pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405080

Locations

United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKV105091
Study First Received:	November 27, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00405080
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Rifampin GW679769

Study placed in the following topic categories:

Rifampin
Vomiting
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Leprostatic Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on January 14, 2009