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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501397
• Other study ID #: KG2108197
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: May 31, 2012
• Start date: February 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ketoconazole

• GSK189075

Locations

Country	Name	City	State
United States	GSK Investigational Site	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3		at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume
Primary	urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3.		at Day 1 Session 1, Days 5 & 6 Session 3.
Secondary	Adverse events: all visits		all visits
Secondary	ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3		Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
Secondary	Labs:followup		followup
Secondary	Urine: Day 1 Session 1,Days 5-6 Session 3		Day 1 Session 1,Days 5-6 Session 3
Secondary	Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup		Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup