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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00437229 |
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.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GW679769 Oral Tablets Drug: dexamethasone oral tablets & intravenous Drug: ondansetron oral tablets & intravenous |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 37 |
Study Start Date: | February 2007 |
Study Completion Date: | May 2007 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | NKV100787 |
Study First Received: | February 16, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00437229 |
Health Authority: | United States: Food and Drug Administration |
Casopitant, GW679769, Dexamethasone, Ondansetron, Healthy Human Volunteer |
Dexamethasone Ondansetron Healthy Serotonin Dexamethasone acetate |
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Antiemetics Hormones Serotonin Antagonists Therapeutic Uses Antipruritics Dermatologic Agents |
Tranquilizing Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Glucocorticoids Pharmacologic Actions Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |