A Study to Assess the Safety of Repeated Doses of GSK189075 and WELLBUTRIN SR in Healthy Male Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. The results will help to determine if doses of GSK189075 and WELLBUTRIN SR can be safely taken together.

Key facts

Study ID: NCT00625859
Run by: GlaxoSmithKline
People needed: 27
Starts: 2008-01-16
Expected to finish: 2008-04-10
Last updated by the study team: 2017-08-24

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

Healthy male subjects aged 18 to 55 years inclusive.
Body Mass Index (BMI) is between 19-35kg/m2 (inclusive), with a minimum body weight of 45kg.
Subject must read and write at a comprehension level that is sufficient to provide written informed consent, and be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Subject has provided informed consent to participate in the study as indicated by providing a signed and dated written informed consent form prior to the initiation of any study procedures.

You may not qualify if…

General
Presence of any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or 12-lead ECG, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study. These include any unstable medical disorder; disorders that would interfere with the action, absorption, distribution, metabolism, or excretion of bupropion or GSK189075; disorders which may pose a safety concern or interfere with the accurate assessment of safety or efficacy.
Laboratory
Clinically significant abnormalities at Screening including:
Systolic blood pressure outside the range of 90 - 140 mmHg, diastolic blood pressure outside the range of 50 - 90 mmHg, and pulse rate at rest > 100 and < 45 bpm.
Positive tests for hepatitis B surface antigen, hepatitis C antibodies, and HIV.
Positive cotinine, drug and/or alcohol test.
Significant ECG abnormalities are defined as follows:
Parameter Range
Heart Rate < 40 and >100 bpm
PR Interval <120 and > 220 ms
QRS duration < 70 and >120 ms
QTC Interval (Bazett) > 450 ms
ALT, alkaline phosphatase, or total bilirubin ³ 1.5 times the upper limits of normal (Note: Subjects with an increased total bilirubin may enter the study only if direct bilirubin is within normal limits).
Fasting triglycerides >400 mg/dL (>11.3 mmol/L).
Clinically significant abnormalities of T3 and TSH.
Serum creatinine clearance <60ml/min (estimated from serum creatinine (SCr) and demographic data using the MDRD calculation):
A validated web-based calculator is found at:
http://nephron.com/cgi-bin/MDRDSIdefault.cgi
To calculate estimated GFR (mL/min/1.73m2) manually:
= 186 x (SCr in mg/dL)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if African-American)
= exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American))
Any other clinically significant laboratory abnormality as determined by the Principal Investigator in consultation with the GSK Medical Monitor.
Central Nervous System
Current diagnosis or a previous history of mania, psychosis, major depression, or other major psychiatric disorder.

Where it is running

GSK Investigational Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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