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

NCT ID: NCT00437229

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-19
• Study Completion Date: 2007-05-15

Brief 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

Keywords

GW679769,; Casopitant,; Dexamethasone,; Healthy Human Volunteer; Ondansetron,

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Casopitant (GW679769) Oral Tablets

Intervention Type: DRUG

Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.

dexamethasone

Intervention Type: DRUG

Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.

ondansetron

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Casopitant (GW679769) Oral Tablets

Intervention Type: DRUG

Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.

dexamethasone

Intervention Type: DRUG

Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.

ondansetron

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

dexamethasone

Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19205755 (View on PubMed)

Other Identifiers

NKV100787

Identifier Type: -

Identifier Source: org_study_id