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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437229
First Posted: February 19, 2007
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Nausea and Vomiting, Chemotherapy-Induced Drug: Casopitant (GW679769) Oral Tablets Drug: dexamethasone Drug: ondansetron Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Actual Study Start Date: February 19, 2007
Study Completion Date: May 15, 2007
Primary Completion Date: May 15, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects in Part A
In PART A, subjects received Regimen A: oral casopitant alone (150 mg once daily [QD] Day 1, 50 mg QD Days 2 and 3); Regimen B: oral dexamethasone (20 mg QD Day 1 and 8 mg twice daily [BID] Days 2 and 3) and intravenous (IV) ondansetron (32 mg single-dose Day 1); and Regimen C: oral casopitant as in Regimen A, IV ondansetron as in Regimen B and a lower dose oral dexamethasone than in Regimen B (12 mg QD Day 1, 8 mg QD Days 2 and 3).
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.
Other Names:
  • GW679769 Oral Tablets
  • dexamethasone oral tablets & intravenous
  • ondansetron oral tablets & intravenous
Experimental: Subjects in Part B
In PART B, subjects received Regimen D: oral casopitant alone (150 mg QD Day 1, 50 mg QD Days 2 and 3); Regimen E: IV dexamethasone (8 mg single-dose Day 1 only) and oral ondansetron (8 mg BID Days 1 to 3); and Regimen F: oral casopitant regimen as in Regimen D, and IV dexamethasone and oral ondansetron as in Regimen E.
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.
Other Names:
  • GW679769 Oral Tablets
  • dexamethasone oral tablets & intravenous
  • ondansetron oral tablets & intravenous

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 GlaxoSmithKline
  More Information

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437229     History of Changes
Other Study ID Numbers: NKV100787
First Submitted: February 16, 2007
First Posted: February 19, 2007
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
GW679769,
Casopitant,
Dexamethasone,
Healthy Human Volunteer
Ondansetron,

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Casopitant
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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