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

NCT00404274 | Completed Phase 1

• 1 other identifier: NKV105097
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nausea and Vomiting, Chemotherapy-Induced

Keywords

healthy human volunteer; GW679769; warfarin; casopitant

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

  throughout the study

Study Arms (3)

Treatment regimen A

EXPERIMENTAL

In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day \[mg/day\], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin.

Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets

Treatment regimen B

EXPERIMENTAL

In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days.

Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets

Treatment regimen C

EXPERIMENTAL

In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days.

Drug: Casopitant (GW679769) oral tablets; Drug: Warfarin oral tablets

Interventions

Casopitant (GW679769) oral tablets DRUG

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

Treatment regimen A; Treatment regimen B; Treatment regimen C

Warfarin oral tablets DRUG

Warfarin will be available in the dose strength of 5 mg

Also known as: Casopitant (GW679769) oral tablets

Treatment regimen A; Treatment regimen B; Treatment regimen C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Gainesville, Florida, 32605, United States

Location

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• Kirby LC, Johnson BM, Adams 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):566-75. doi: 10.1177/0091270009346965. Epub 2010 Mar 10.

  PMID: 20220045 RESULT

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 NKV105097 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

casopitant; Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2006
• First Posted: November 28, 2006
• Study Start: November 1, 2006
• Primary Completion: March 18, 2007
• Study Completion: March 18, 2007
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)