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Completed

NCT Number: NCT00405080

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

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

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Key information

Conditions

Nausea and Vomiting, Chemotherapy-Induced Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

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.

Other names: GW679769 (Casopitant) oral tablets

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.

    Time frame: Up to Day 10

Secondary outcomes

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

    Time frame: Up to Day 12

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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]

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 29, 2006
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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