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NCT Number: NCT00404274

A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers

GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects
  • non-smoking
  • Females cannot be able to have children
  • Must be able to swallow and retain oral medication
  • Understand and sign the written consent
  • comply with the requirements and restrictions involved in an overnight 30 day confinement in a healthcare setting

Exclusion criteria

  • cannot participate if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
  • blood donation in excess of 1 pint within 56 days before dosing of medication
  • iron deficiency
  • 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
  • use of prescription or non-prescription drug(s), herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
  • consumption of any food or drink containing grapefruit, Seville oranges, kumquats, pomelos (or their juices) within 7 days of the first dose of study medication
  • history of bleeding disorders or excessive bleeding
  • female who has a positive pregnancy test
  • female who is lactating

Treatment and study plan

Casopitant (GW679769) oral tablets

Drug

Casopitant will be available in the dose strength of 20,30 or 50 mg

Warfarin oral tablets

Drug

Warfarin will be available in the dose strength of 5 mg

Other names: Casopitant (GW679769) oral tablets

Primary outcomes

  1. Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.

    Time frame: Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16.

  2. Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16.

    Time frame: Period 2: Day 2 & 3 and Day 5 to 16.

Secondary outcomes

  1. Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin When Co-administered With Repeat Doses of Casopitant [GW679769] in Healthy Adult Subjects.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 28, 2006
Registry last updated
Aug 9, 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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