Albiglutide Thorough ECG Study in Healthy Volunteers

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

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-06

Study Completion Date

2011-12-29

Brief Summary

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This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

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Detailed Description

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This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Albiglutide + moxifloxacin placebo

Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40

Group Type ACTIVE_COMPARATOR

Albiglutide

Intervention Type BIOLOGICAL

once weekly subcutaneous injection

Albiglutide matching placebo + moxifloxacin

Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

oral tablet

Interventions

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Albiglutide

once weekly subcutaneous injection

Intervention Type BIOLOGICAL

Moxifloxacin

oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or nonpregnant, nonlactating female
* Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
* BMI is ≥18 kg/m2 and ≤30 kg/m2
* Nonsmoker

Exclusion Criteria

* Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
* History of arrythmia or use of antiarrhythmic agents
* History of any anaphylactic reaction to any drug
* History of significant cardiovascular or pulmonary dysfunction
* Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
* History of alcohol or substance abuse
* History of GI surgery that could influence gastric emptying
* Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
* History of pancreatitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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

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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