A Single-Blind, Randomized, Placebo-Controlled, Ascending Single Dose and Repeat Dose Study With Once Daily Dosing To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 in Healthy Overweight and Obese Subjects

GlaxoSmithKline1 site in 1 country70 target enrollmentJune 2007

ConditionsType 2 Diabetes Mellitus

DrugsGSK376501 Placebo

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: GlaxoSmithKline
Enrollment: 70
Locations: 1
Primary Endpoint: Adverse reactions and changes in laboratory values, vital signs, and/or ECGs following each dose
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study represents the second Phase 1 study with GSK376501 and the goal is to further evaluate its safety and tolerability. The way the human body processes GSK376501 will also be determined.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

December 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•The subject is healthy and overweight/obese, defined as having a body mass index greater than 25 but less than 35kg/m2, inclusive.
•The subject is an adult male or a female of non-childbearing potential between the age of 18 and 65 years, inclusive, at the time of signing informed consent.
•The subject and their partner are willing to use double-barrier method of contraception from the first day of study drug administration until 5 half-lives of the drug have elapsed following the last day of study drug administration.
•The subject demonstrates an ECG with values within ranges specified in the protocol at screening or baseline.
•The subject is capable of giving written informed consent, which includes the ability to read, comprehend and comply with the protocol requirements and restrictions as described in the consent form.

Exclusion Criteria

•Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any medication that is chemically related to the study drug or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation in the study.
•Has a known allergy to any of the tablet formulation excipients of GSK376501 or pioglitazone (as applicable).
•Has sensitivity to heparin or history of heparin-induced thrombocytopenia.
•Has a history of alcohol abuse or dependence within 12 months prior to the study.
•Has a positive alcohol test at screening or baseline and/or is unwilling to abstain from alcohol for 72 hours prior to the start of dosing until discharged from the clinic and for 72 hours prior to the follow-up visit.
•Is unwilling to abstain from caffeine- or xanthine-containing products for 24 hours prior to each dose and throughout each in-house period, and for 24 hours prior to the follow-up visit.
•The subject smokes or has used tobacco or nicotine-containing products within the 6 months prior to the study, or is positive for urine cotinine at screening or at baseline.
•Is unwilling to refrain from the use of tobacco or illicit drugs during the trial, and/or tests positive for urine cotinine or drugs of abuse at screening or at baseline. At minimum, the list of drugs or classes of drugs that will be screened for include the following: amphetamines, barbiturates, benzoylecgonine, benzodiazepines, cannabinoids, cotinine, and opiates.
•Where participation in the study would result in donation of blood in excess of 500 ml within a 56 day period.
•Has a systolic blood pressure outside the range of 140 to 90mmHg, a diastolic blood pressure outside the range of 90 to 60mmHg and/or a heart rate outside the range of 90 to 45bpm, inclusive, at screening or at baseline.

Outcomes

Primary Outcomes

Adverse reactions and changes in laboratory values, vital signs, and/or ECGs following each dose

Time Frame: following each dose

Secondary Outcomes

Blood levels of GSK376501 following 1 day (Part A) or 14 days (Part B) of dosing(following 1 day (Part A) or 14 days (Part B) of dosing)
GSK376501 plasma levels to derive pharmacokinetic parameters following single and repeat doses for 14 days
Standard markers that may serve as possible surrogates of volume expansions with GSK376501.
Body weight following 14 days of repeat dosing with GSK376501.