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

Primary Purpose

Nausea and Vomiting, Chemotherapy-Induced

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GW679769 (Casopitant) oral tablets

Rifampin oral capsules

About this trial

This is an interventional treatment trial for Nausea and Vomiting, Chemotherapy-Induced focused on measuring Rifampin GW679769

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Period 1

Treatment Period 2

Arm Description

Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.

Subjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

clinical lab tests adverse events vital signs 12 lead ECGs liver function tests

Full Information

NCT ID

NCT00405080

First Posted

November 27, 2006

Last Updated

September 11, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00405080

Brief Title

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

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]

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

November 11, 2006 (Actual)

Primary Completion Date

January 5, 2007 (Actual)

Study Completion Date

January 5, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting, Chemotherapy-Induced

Keywords

Rifampin GW679769

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Period 1

Arm Type

Experimental

Arm Description

Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.

Arm Title

Treatment Period 2

Arm Type

Experimental

Arm Description

Subjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin.

Intervention Type

Drug

Intervention Name(s)

GW679769 (Casopitant) oral tablets

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rifampin oral capsules

Other Intervention Name(s)

GW679769 (Casopitant) oral tablets

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Time Frame

Up to Day 10

Secondary Outcome Measure Information:

Title

clinical lab tests adverse events vital signs 12 lead ECGs liver function tests

Time Frame

Up to Day 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98418

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

NKV105091

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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