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CompletedNCT00537719Updated Aug 17, 2017

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

A Phase 1 interventional study of GSK716155 and Placebo in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • healthy
  • pharmacodynamics
  • glucagon-like peptide 1
  • pharmacokinetics
  • scintigraphy
  • radiation
  • albiglutide
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    GSK716155

    albiglutide subcutaneous injection

    Drug: GSK716155

  • Placebo comparator
    placebo

    placebo injection

    Drug: Placebo

Interventions

  • DrugGSK716155

    albiglutide subcutaneous injection

  • DrugPlacebo

    placebo injection

    Also known as: GSK716155

06

What researchers measure

Primary outcomes

  1. Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers.

    Time frame: 3 Days

Secondary outcomes

  1. Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit.

    Time frame: 3 Days

07

Study locations

1 site
  • GSK Investigational Site
    Lexington, Kentucky 40503, United States
08

References and documents

Publications

  • 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. PubMed 25387217 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00537719
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 1, 2007
Start date
Dec 7, 2007
Primary completion
Apr 4, 2008
Completion
Apr 4, 2008
Last update
Aug 17, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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