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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: ketoconazole; Drug: GSK189075

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Adverse events: all visits	all visits
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
Labs:followup	followup
Urine: Day 1 Session 1,Days 5-6 Session 3	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	Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: February 1, 2007

Study Registration Dates

• First Submitted: July 13, 2007
• First Submitted That Met QC Criteria: July 13, 2007
• First Posted (Estimate): July 16, 2007

Study Record Updates

• Last Update Posted (Estimate): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; T2DM,; ketoconazole,; drug interaction,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: KG2108197