Clinical trial NCT00437229: A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
Official title: An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: GW679769,
Casopitant,
Dexamethasone,
Healthy Human Volunteer
Ondansetron,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: checked on Day 1, 2 and/or 3
Secondary outcomes:
measure: Safety is evaluated by: Clinical Lab Tests done
timeFrame: at Screening, Day -1 & Followup.
measure: Vitals Signs taken & Adverse Events monitored
timeFrame: at each visit starting at Day -1.
measure: 12 lead ECGs & Serum Pepsinogen level tests
timeFrame: at Screening & Followup.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Johnson B, Adams L, Lu E, Zhang K, Lebowitz P, Lates C, Blum R. Impact of casopitant, a novel NK-1 antagonist, on the pharmacokinetics of ondansetron and dexamethasone. Support Care Cancer. 2009 Sep;17(9):1177-85. doi: 10.1007/s00520-008-0571-5. Epub 2009 Feb 10.