NCT00437229

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nausea and Vomiting, Chemotherapy-Induced

Interventions

Type	Name	Description
DRUG	Casopitant (GW679769) Oral Tablets	Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
DRUG	dexamethasone	Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
DRUG	ondansetron	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.

Timeline

• Start date: 2007-02-19
• Primary completion: 2007-05-15
• Completion: 2007-05-15
• First posted: 2007-02-19
• Last updated: 2017-11-13

Locations

1 site across 1 country: United States