Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed
 and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized
 albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen
 injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will
 enable the use of a liquid product in a ready-to-use single dose auto-injector. To support
 the development of the liquid auto-injector product, this healthy volunteer bioequivalence
 study will be conducted to compare the liquid drug product to the currently available
 lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose,
 2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics
 and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial
 lyophilized drug product.
Inclusion Criteria:

 -  Between 18 and 65 years of age.

 -  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:

 -  Alanine aminotransferase (ALT) >1.5 x upper limit of normal range (ULN)

 -  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