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OpenTrials
Completed

NCT Number: NCT00437229

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Buffalo, New York, 14202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Dexamethasone

Drug

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

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.

Other names: GW679769 Oral Tablets, dexamethasone oral tablets & intravenous, ondansetron oral tablets & intravenous

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.

    Time frame: checked on Day 1, 2 and/or 3

Secondary outcomes

  1. Safety is evaluated by: Clinical Lab Tests done

    Time frame: at Screening, Day -1 & Followup.

  2. Vitals Signs taken & Adverse Events monitored

    Time frame: at each visit starting at Day -1.

  3. 12 lead ECGs & Serum Pepsinogen level tests

    Time frame: at Screening & Followup.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 19, 2007
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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