Last updated: 11/04/2018 09:49:17

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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GSK study ID
NKV105091
See study documents
Clinicaltrials.gov ID
NCT00405080
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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]
Trial description: This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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.

Timeframe: Up to Day 10

Secondary outcomes:

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

Timeframe: Up to Day 12

Interventions:
Drug: GW679769 (Casopitant) oral tablets
Drug: Rifampin oral capsules
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
casopitant
Collaborators
Not applicable
Study date(s)
November 2006 to January 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
  • healthy
  • female subjects who cannot become pregnant
  • smokes at least 4 packs per day in the past 12 months
  • use of prescription or non-prescription drug(s)
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Tacoma, Washington, United States, 98418
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-05-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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