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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- GlaxoSmithKline
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
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.
Time Frame: throughout the study
Secondary Outcomes
- Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers(throughout the study)