Albiglutide Thorough ECG Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01406262
First received: July 28, 2011
Last updated: November 23, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: Albiglutide
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • QTc interval [ Time Frame: 6 weeks ]
    Measurement of cardiac repolarization after albiglutide dosing


Secondary Outcome Measures:
  • QTc interval [ Time Frame: Day 4 ]
    Measurement of cardiac repolarization after albiglutide dosing

  • QT interval [ Time Frame: Day -1 and Day 40 ]
    Determination of the effect of moxifloxacin on cardiac repolarization

  • Number of participants with adverse events [ Time Frame: 6 weeks ]
    Number of participants with adverse events


Enrollment: 94
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Albiglutide + moxifloxacin placebo
Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40
Biological: Albiglutide
once weekly subcutaneous injection
Active Comparator: 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
Drug: Moxifloxacin
oral tablet

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406262

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107085
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01406262     History of Changes
Other Study ID Numbers: 107085 
Study First Received: July 28, 2011
Last Updated: November 23, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
albiglutide
QT interval
cardiac repolarization
ECG study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
rGLP-1 protein
Glucagon-Like Peptide 1
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on January 24, 2017