A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults

Condition(s) targeted: Healthy Subjects; Nausea and Vomiting, Chemotherapy-Induced

Intervention: GW679769 Oral Tablets (Drug); dexamethasone oral tablets & intravenous (Drug); ondansetron oral tablets & intravenous (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant [GW679769] and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

Safety is evaluated by: Clinical Lab Tests done

Vitals Signs taken & Adverse Events monitored

12 lead ECGs & Serum Pepsinogen level tests

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

GSK Investigational Site, Buffalo, New York 14202, United States

Related publications:

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.

Starting date: February 2007
Last updated: May 31, 2012