NCT00625859

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2008

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

February 19, 2008

Last Update Submit

August 23, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacodynamicsHealthy adult male volunteers,pharmacokinetics,

Outcome Measures

Primary Outcomes (1)

  • Blood samples and urine samples

    on Day 14

Secondary Outcomes (8)

  • adverse events, heart rate & blood pressure: each visit ecg: screening, days -1, 1, 4, 7, 13, 14, followup lab tests: screening, days -1, 4, 7, 13, 14, followup

    Up to Week 12

  • GSK189074 Cmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.

    Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours

  • Bupropion and GSK189074 tmax at steady-state when GSK189075 is administered alone and following co-administration with WELLBUTRIN SR.

    Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours

  • Steady-state AUC(0-12), Cmax, and tmax of the bupropion metabolites (hydroxybupropion, threohydrobupropion and erythrohydrobupropion) when WELLBUTRIN SR is administered alone and with GSK189075.

    Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours

  • Steady-state AUC(0-12), Cmax, and tmax of GSK189075, and GSK279782 when GSK189075 is administered alone and with WELLBUTRIN SR.

    Pre-dose, 0.25, 0.5, 1,2, 3, 4, 6, 8,10, 12, 16, 20 and 24hours

  • +3 more secondary outcomes

Study Arms (6)

Subjects receiving treatment sequence 1

EXPERIMENTAL

Eligible subjects will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Subjects receiving treatment sequence 2

EXPERIMENTAL

Eligible subjects will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Subjects receiving treatment sequence 3

EXPERIMENTAL

Eligible subjects will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Subjects receiving treatment sequence 4

EXPERIMENTAL

Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Subjects receiving treatment sequence 5

EXPERIMENTAL

Eligible subjects will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Subjects receiving treatment sequence 6

EXPERIMENTAL

Eligible subjects will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. A= Bupropion SR + GSK189075 placebo, B= Bupropion SR placebo + GSK189075 and C= Bupropion SR + GSK189075

Drug: GSK189075Drug: BupropionDrug: Placebo

Interventions

GSK189075DRUG

GSK189075 will be available as film-coated tablets with a dose of 250 milligrams.

Subjects receiving treatment sequence 1Subjects receiving treatment sequence 2Subjects receiving treatment sequence 3Subjects receiving treatment sequence 4Subjects receiving treatment sequence 5Subjects receiving treatment sequence 6
BupropionDRUG

Bupropion will be available as sustained release film-coated tablets with a dose of 150 milligrams administered orally.

Subjects receiving treatment sequence 1Subjects receiving treatment sequence 2Subjects receiving treatment sequence 3Subjects receiving treatment sequence 4Subjects receiving treatment sequence 5Subjects receiving treatment sequence 6
PlaceboDRUG

Placebo tablets will be given to subjects.

Subjects receiving treatment sequence 1Subjects receiving treatment sequence 2Subjects receiving treatment sequence 3Subjects receiving treatment sequence 4Subjects receiving treatment sequence 5Subjects receiving treatment sequence 6

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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).
  • +40 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

January 16, 2008

Primary Completion

April 10, 2008

Study Completion

April 10, 2008

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

US(1)