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

Nausea and Vomiting, Chemotherapy-Induced Clinical Trial

Official 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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405080
• Other study ID #: NKV105091
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2006
• Last updated: September 11, 2017
• Start date: November 11, 2006
• Est. completion date: January 5, 2007

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 5, 2007
• Est. primary completion date: January 5, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea and Vomiting, Chemotherapy-Induced
• Vomiting

Intervention

Drug:
• GW679769 (Casopitant) oral tablets
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
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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Up to Day 10
Secondary	clinical lab tests adverse events vital signs 12 lead ECGs liver function tests		Up to Day 12

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 NKV105091 can be found on the GSK Clinical Study Register.