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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00437229

Purpose

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
Healthy Subjects	Drug: GW679769 Oral Tablets Drug: dexamethasone oral tablets & intravenous Drug: ondansetron oral tablets & intravenous	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Casopitant Casopitant mesylate GW679769 Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. [ Time Frame: checked on Day 1, 2 and/or 3 ]

Secondary Outcome Measures:

Safety is evaluated by: Clinical Lab Tests done [ Time Frame: at Screening, Day -1 & Followup. ]
Vitals Signs taken & Adverse Events monitored [ Time Frame: at each visit starting at Day -1. ]
12 lead ECGs & Serum Pepsinogen level tests [ Time Frame: at Screening & Followup. ]

Enrollment:	37
Study Start Date:	February 2007
Study Completion Date:	May 2007

Intervention Details:

Other Names:

GW679769 Oral Tablets
dexamethasone oral tablets & intravenous
ondansetron oral tablets & intravenous

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437229

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00437229 History of Changes
Other Study ID Numbers:	NKV100787
Study First Received:	February 16, 2007
Last Updated:	May 15, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Casopitant,
GW679769,
Dexamethasone,
Ondansetron,
Healthy Human Volunteer

Additional relevant MeSH terms:

Dexamethasone acetate
Dexamethasone
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 09, 2012