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

Nausea and Vomiting, Chemotherapy-Induced Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404274
• Other study ID #: NKV105097
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2006
• Last updated: August 8, 2017
• Start date: November 1, 2006
• Est. completion date: March 18, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 18, 2007
• Est. primary completion date: March 18, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea and Vomiting, Chemotherapy-Induced
• Vomiting

Intervention

Drug:
• Casopitant (GW679769) oral tablets
Casopitant will be available in the dose strength of 20,30 or 50 mg
• Warfarin oral tablets
Warfarin will be available in the dose strength of 5 mg

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests		throughout the study

External 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.