A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: ketoconazole (Drug); GSK189075 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete’s foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.

Official title: An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study

Primary outcome:

Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3

urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3.

Secondary outcome:

Adverse events: all visits

ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3

Labs:followup

Urine: Day 1 Session 1,Days 5-6 Session 3

Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Are a healthy, non-smoking male or female.

- Are 18 to 55 years old, inclusive.

- Have a body weight of > or equal to 110 pounds.

- Are a female who is unable to have any more children and have a negative pregnancy

test.

- Are willing and able to provide written informed consent before the start of any

study-related procedures.

- Are able to understand and comply with protocol requirements, instructions, and

protocol-stated restrictions.

Exclusion Criteria:

- Smoke or use any tobacco products.

- Have a known allergic reaction to ketoconazole or study drug.

- Have a history of regular alcohol consumption greater than 7 drinks per week for

females or greater than 14 drinks per week for males.

- Have a positive drug or alcohol or smoking test at screening or check-in to the

clinic.

- Have participated in another clinical trial within 30 days prior to screening in which

you have received an investigational drug.

- Have donated a pint of blood within 56 days before the first dose of study drug.

- Have any known or suspected stomach condition (or stomach surgery within the 6 months

prior to dosing).

- Have abnormal liver test results.

- Have a documented history or diagnosis of cirrhosis.

- Have positive results for hepatitis C or B, or HIV at screening.

- Have blood pressure outside of the normal range.

- Are a male subject who is unwilling to either abstain from sexual activity or

unwilling to use birth control during the course of the study.

- Are using non-prescription drugs, vitamins, herbal or dietary supplements (including

St John’s Wort) within 7 days before the first dose of study medication,

- Have any abnormality identified on the screening physical or laboratory examination

that the study physician feels would make it inappropriate for you to participate in the study.

GSK Clinical Trials Call Center, Columbus, Ohio 43210, United States

Starting date: February 2007
Last updated: July 13, 2007