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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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00405080
First received: November 27, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

November 27, 2006
May 31, 2012
November 2006
Not Provided
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.
  • 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.
Complete list of historical versions of study NCT00405080 on ClinicalTrials.gov Archive Site
clinical lab tests adverse events vital signs 12 lead ECGs liver function tests
  • Clinical lab tests
  • adverse events
  • vital signs
  • 12 lead ECGs
  • liver function tests
Not Provided
Not Provided
 
A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emesis
  • Nausea and Vomiting, Chemotherapy-Induced
  • Drug: GW679769 (Casopitant) oral tablets
  • Drug: Rifampin oral tablets
    Other Names:
    • GW679769 (Casopitant) oral tablets
    • Rifampin oral tablets
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Not Provided
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405080
NKV105091
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP