Status:
COMPLETED
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nausea and Vomiting, Chemotherapy-Induced
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels...
Eligibility Criteria
Inclusion
- Healthy adult males or females
- Age: 18 to 55 years, inclusive
- A female subject who is non-childbearing potential or using acceptable contraceptive methods.
- Adequate organ systems function
- Able to swallow and retain oral medication
- Able to understand and comply with protocol requirements and instruction and is likely to complete the study.
Exclusion
- Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
- History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
- Use of an investigation drug within 28 days or 5 half-lives.
- Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
- Presence of or suspected iron deficiency
- Positive stool for occult blood
- Female subject who is lactating
- Positive urine drug screen
- Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
- Use of tobacco-containing products within the past 12 months prior to screening
- History of drug or alcohol abuse or dependence within 6 months of screening
- History or presence of uncontrolled emesis
- Positive purified protein derivative (PPD) skin test for tuberculosis
Key Trial Info
Start Date :
February 19 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2007
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00437229
Start Date
February 19 2007
End Date
May 15 2007
Last Update
November 13 2017
Active Locations (1)
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1
GSK Investigational Site
Buffalo, New York, United States, 14202