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

NCT00437229 | Completed Phase 1

• 1 other identifier: NKV100787
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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,

Outcome Measures

Primary Outcomes (1)

• 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.

  checked on Day 1, 2 and/or 3

Secondary Outcomes (3)

• Safety is evaluated by: Clinical Lab Tests done

  at Screening, Day -1 & Followup.

• Vitals Signs taken & Adverse Events monitored

  at each visit starting at Day -1.

• 12 lead ECGs & Serum Pepsinogen level tests

  at Screening & Followup.

Study Arms (2)

Subjects in Part A

EXPERIMENTAL

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; Drug: dexamethasone; Drug: ondansetron

Subjects in Part B

EXPERIMENTAL

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; Drug: dexamethasone; Drug: ondansetron

Interventions

Casopitant (GW679769) Oral Tablets DRUG

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

Subjects in Part A; Subjects in Part B

dexamethasone DRUG

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

Subjects in Part A; Subjects in Part B

ondansetron 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.

Also known as: GW679769 Oral Tablets, dexamethasone oral tablets & intravenous, ondansetron oral tablets & intravenous

Subjects in Part A; Subjects in Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• 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.

  PMID: 19205755 BACKGROUND

Related Links

• Results for study 100787 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

casopitant; Dexamethasone; Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 19, 2007
• Primary Completion: May 15, 2007
• Study Completion: May 15, 2007
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

US (1)