Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
NCT ID: NCT02660736
Last Updated: 2016-11-09
Study Results
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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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2016-02-29
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Regimen AB
Subjects will be receive Regimen A treatment in Session 1 followed by Regimen B treatment in Session 2.
Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector.
Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector.
A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2.
Albiglutide Liquid Auto-injector
Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose
Albiglutide Lyophilized DCC Pen Injector
Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL
Placebo Liquid Auto-injector
Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.
Placebo Lyophilized DCC Pen injector
Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
Regimen BA
Subjects will be receive Regimen B treatment in Session 1 followed by Regimen A treatment in Session 2.
Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector.
Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector.
A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2.
Albiglutide Liquid Auto-injector
Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose
Albiglutide Lyophilized DCC Pen Injector
Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL
Placebo Liquid Auto-injector
Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.
Placebo Lyophilized DCC Pen injector
Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
Interventions
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Albiglutide Liquid Auto-injector
Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose
Albiglutide Lyophilized DCC Pen Injector
Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL
Placebo Liquid Auto-injector
Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.
Placebo Lyophilized DCC Pen injector
Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
Eligibility Criteria
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Inclusion Criteria
* Healthy.
* Subject is a nonsmoker.
* Subject's body mass index (BMI) is \>=18 kilogram/meter square (kg/m\^2) and \<=30 kg/m\^2
* Male or
* Female
Exclusion Criteria
* Bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) \> 450 millisecond (msec).
* Systolic blood pressure is \>=140 millimeter of mercury (mmHg) at Screening;
* Diastolic blood pressure is \>=90 mmHg at Screening;
* Heart rate is \>100 beats/min at Screening.
* estimated glomerular filtration rate (eGFR) \<=80 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) at Screening.
* Fasting triglyceride level \>300 milligram per deciliter (mg/dL) at Screening.
* History of significant cardiovascular or pulmonary dysfunction prior to Screening.
* History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at Screening.
* History of gastrointestinal surgery that could influence gastric emptying (e.g., gastrectomy, gastric bypass).
* History of pancreatitis.
* Personal or family history of multiple endocrine neoplasia type 2.
* Personal or family history of medullary carcinoma of the thyroid.
* Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days.
* History of regular alcohol consumption within 6 months of the study.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
* Subject has previously received any GLP-1 mimetic compound (eg., exenatide, liraglutide, lixisenatide, dulaglutide).
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* Subject has donated blood in excess of 500 mL within 56 days prior to dosing or intention of donating in the month after completing the study.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
18 Years
65 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Austin, Texas, United States
Countries
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References
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Shaddinger BC, Vlasakakis G, Soffer J, Thorpe KM, Hatch D, Nino AJ. A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2019 Apr;8(3):361-370. doi: 10.1002/cpdd.606. Epub 2018 Jul 31.
Other Identifiers
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201287
Identifier Type: -
Identifier Source: org_study_id