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

Nausea and Vomiting, Chemotherapy-Induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437229
• Other study ID #: NKV100787
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2007
• Last updated: November 8, 2017
• Start date: February 19, 2007
• Est. completion date: May 15, 2007

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 15, 2007
• Est. primary completion date: May 15, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea and Vomiting, Chemotherapy-Induced
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety is evaluated by: Clinical Lab Tests done		at Screening, Day -1 & Followup.
Secondary	Vitals Signs taken & Adverse Events monitored		at each visit starting at Day -1.
Secondary	12 lead ECGs & Serum Pepsinogen level tests		at Screening & Followup.

External Links

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