Albiglutide Thorough ECG Study in Healthy Volunteers

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Moxifloxacin; Biological: Albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406262

107085

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Albiglutide + moxifloxacin placebo

Active Comparator group

Description:

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

Treatment:

Biological: Albiglutide

Albiglutide matching placebo + moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin