Clinical Trials/NCT01607385

NCT01607385

Completed

Phase 1

A Single Blind, Randomized, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability,Pharmacokinetic and Pharmacodynamic Parameters of Repeat Doses of GSK2330672 in Healthy Volunteers, Given Alone and With a Single Day of Dosing With GSK1614235

GlaxoSmithKline1 site in 1 country56 target enrollmentMay 18, 2012

ConditionsDiabetes Mellitus, Type 2

InterventionsGSK2330672 GSK1614235 Placebo

DrugsGSK2330672 Placebo GSK1614235

Overview

Phase: Phase 1
Intervention: GSK2330672
Conditions: Diabetes Mellitus, Type 2
Sponsor: GlaxoSmithKline
Enrollment: 56
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A single blind, randomized, placebo-controlled, dose escalating study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic parameters of repeat doses of GSK2330672 in healthy volunteers, given alone and with a single day of dosing with GSK1614235

Registry

clinicaltrials.gov

Start Date

May 18, 2012

End Date

December 3, 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Laboratory assessments may be repeated if outside of normal ranges. The Investigator may interpret screening vital sign data based on the subject's age, physical state and level of fitness. Subjects with vital sign readings marginally outside the normal ranges below may be included in the study if in the Investigator's opinion these values are not clinically significant and will not present a safety risk or affect study assessments.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Subjects must understand the aims, investigational procedures and possible consequences of the study and must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
•Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
•A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood sample with simultaneous follicle stimulating hormone greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory in the absence of a clear postmenopausal history; Females on hormone replacement therapy must discontinue hormone replacement therapy to allow confirmation of post-menopausal status prior to study enrollment. For most forms of hormone replacement therapy, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of hormone replacement therapy. Following confirmation of their post-menopausal status, they can resume use of hormone replacement therapy during the study.
•Body mass index within the range 19 - 32kg/m2 (inclusive).

Exclusion Criteria

•ALT, alkaline phosphatase and bilirubin greater than 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%.
•Current or chronic history of inflammatory bowel disease, chronic diarrhea, Crohn's disease or malabsorption syndromes.
•Current or chronic history of cholelithiasis, inflammatory gall bladder disease, cholestatic liver injury, and cholecystectomy.
•Current or chronic history of liver disease, or known hepatic abnormalities (with the exception of Gilbert's syndrome).
•Fecal occult blood positive test at screening.
•Triglycerides greater than 250mg/dL.
•History of chronic or acute pancreatitis.
•Mean QTc greater than and equal to 450msec on three tracings obtained at least 5 minutes apart.
•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
•A positive test for HIV antibody.

Arms & Interventions

GSK2330672

Intervention: GSK2330672

GSK2330672

Intervention: GSK1614235

Placebo

Intervention: Placebo

Placebo

Intervention: GSK1614235

Outcomes

Primary Outcomes

Adverse events

Time Frame: 3 weeks

Gastrointestinal Symptom Rating Scale

Time Frame: 2 weeks

Tolerability of possible gastic side effets.

Clinical laboratory tests for safety.

Time Frame: 7 weeks

Regular clinical chemistry and hematology panels.

Bristol Stool Form Scale

Time Frame: 2 weeks

Frequency of bowel movements and quality of stool samples.

Secondary Outcomes

Pharmacokinetic measures of GSK2330672.(Change from baseline at 2 weeks.)
Pharmcokinetic measures of GSK2330672, GSK1614235, GSK2313533, and GSK2313537.(Full profiles on Day 13.)