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

September 11, 2017 updated by: GlaxoSmithKline

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]

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98418
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Period 1
Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.
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.
Experimental: Treatment Period 2
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.
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.
Drug: 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.
Other Names:
  • GW679769 (Casopitant) oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to Day 10

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical lab tests adverse events vital signs 12 lead ECGs liver function tests
Time Frame: Up to Day 12
Up to Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2006

Primary Completion (Actual)

January 5, 2007

Study Completion (Actual)

January 5, 2007

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (Estimate)

November 29, 2006

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV105091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Clinical Study Report
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: NKV105091
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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