Nausea and Vomiting, Chemotherapy-Induced
Conditions
Keywords
GW679769,, Casopitant,, Dexamethasone,, Healthy Human Volunteer, Ondansetron,
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 in humans.
Interventions
Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
DRUGdexamethasone
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
DRUGondansetron
Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. | checked on Day 1, 2 and/or 3 |
Secondary
| Measure | Time frame |
|---|---|
| Safety is evaluated by: Clinical Lab Tests done | at Screening, Day -1 & Followup. |
| Vitals Signs taken & Adverse Events monitored | at each visit starting at Day -1. |
| 12 lead ECGs & Serum Pepsinogen level tests | at Screening & Followup. |
Countries
United States
Outcome results
None listed