Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-07

Study Completion Date

2008-04-04

Brief Summary

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This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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GSK716155

albiglutide subcutaneous injection

Group Type ACTIVE_COMPARATOR

GSK716155

Intervention Type DRUG

albiglutide subcutaneous injection

placebo

placebo injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo injection

Interventions

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GSK716155

albiglutide subcutaneous injection

Intervention Type DRUG

Placebo

placebo injection

Intervention Type DRUG

Other Intervention Names

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GSK716155

Eligibility Criteria

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Inclusion Criteria

* Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32.
* If female, the subject must be not be capable of having children.

Exclusion Criteria

* Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures.
* Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease.
* Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide.
* Prior radiation exposures must meet certain limits in order to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Reference Type DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

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