A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
Status:
Completed
Trial end date:
2015-10-13
Target enrollment:
Participant gender:
Summary
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and
approved for the treatment of type 2 diabetes mellitus. The primary objective of this study
is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder
emptying. To make this assessment, each study participant will receive a dose of albiglutide
and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement
of the gallbladder.
The study will be comprised of two periods and 20 subjects. The screening visit will occur
within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by
a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28
days following the last dose of albiglutide or placebo. The total duration of a subject's
participation from Screening to Follow-up will be approximately 17.5 weeks.
This study is a post marketing commitment to the United States Food and Drug Administration
(USFDA).
Phase:
Phase 4
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Cholecystokinin Glucagon-Like Peptide 1 rGLP-1 protein