Last updated: 11/04/2018 09:50:27

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

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GSK study ID
NKV105097
See study documents
Clinicaltrials.gov ID
NCT00404274
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

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

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

Timeframe: Period 2: Day 2 & 3 and Day 5 to 16.

Secondary outcomes:

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

Timeframe: throughout the study

Interventions:
Drug: Casopitant (GW679769) oral tablets
Drug: Warfarin oral tablets
Enrollment:
97
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kirby LC; Johnson BM; Adamns LM; Eberwein DJ; Zhang K; Murray SC; Lates CD; Blum RA; Morris SR. Effect of Casopitant, a Novel NK-1 Receptor Antagonist, on the Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin. J Clin Pharmacol 2010 May; 50(5):566-575
Kirby LC; Johnson BM; Adamns LM; Eberwein DJ; Zhang K; Murray SC; Lates CD; Blum RA; Morris SR. Effect of Casopitant, a Novel NK-1 Receptor Antagonist, on the Pharmacokinetics and Pharmacodynamics of Steady-State Warfarin. J Clin Pharmacol 2010 May; 50(5):566-575
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
casopitant
Collaborators
Not applicable
Study date(s)
November 2006 to March 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • Healthy subjects
  • non-smoking
  • 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
Inclusion and exclusion criteria
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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Gainesville, Florida, United States, 32605
Status
Study Complete
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Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-18-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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