Last updated: 11/04/2018 06:10:23
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
GSK study ID
DIX109177
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)
Trial description: This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes.
Timeframe: throughout the study
Secondary outcomes:
Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers
Timeframe: throughout the study
Interventions:
Drug: placebo
Drug: GSK376501
Enrollment:
72
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
GSK376501
Collaborators
Not applicable
Study date(s)
October 2006 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
yes
- Inclusion:
- Healthy
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion:
- Healthy
- Non-smoking
- Overweight or obese subjects with a BMI between 27 and 35. Exclusion:
- Women who are pregnant, lactating, or are of child-bearing potential
Trial location(s)
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-07-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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