GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects

A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI ≥18•Healthy volunteers

Primary endpoints

•AUC from 0 to the last measurable concentration (AUC 0-t) for albiglutide•AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2•Peak plasma concentration (Cmax) for albiglutide in session 1 and 2

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02660736

Org study ID201287

Timeline

Milestones

Study first posted2016-01-21estimated

Last update posted2016-11-09estimated

Study start2016-02 (month precision)

Primary completion2016-08actual (month precision)

Study completion2016-08actual (month precision)

Assets

Investigational agents

Albiglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Safety as assessed by systolic, diastolic blood pressure, and pulse rate measurements

Time frame:Up to 21 weeks

descriptive

Safety / tolerability / PK

13 endpoints

Primary/protocol endpoint

Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2