Last updated: 07/17/2020 18:20:06
Bioequivalence study of Two Albiglutide Drug Products in Healthy Adult Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Peak plasma concentration (Cmax) for albiglutide in session 1 and 2
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Secondary outcomes:
Time to maximal concentration (Tmax) for albiglutide in session 1 and 2
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Clearance (CL/F) for albiglutide in session 1 and 2.
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Volume of distribution (V/F) for albiglutide in session 1 and 2
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Number of subjects with adverse events (AE) and clinical observations as a measure of safety and tolerability
Timeframe: Up to 21 weeks
Safety as assessed by 12-lead electrocardiogram (ECG)
Timeframe: Screening, Day -1, Day 4, and Day 35 in both sessions 1 and 2
Safety as assessed by systolic, diastolic blood pressure, and pulse rate measurements
Timeframe: Up to 21 weeks
Immunogenicity as assessed by enzyme-linked immunosorbent assay (ELISA) and hypersensitivity reactions.
Timeframe: Day 1 in both sessions and Day 13 in session 1 and follow-up visit
Half-life (T1/2) for albiglutide in session 1 and 2
Timeframe: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2.
Composite of hematology parameters as a measure of safety
Timeframe: Up to 21 weeks
Composite of clinical chemistry parameters as a measure of safety
Timeframe: Up to 21 weeks
Composite of urinalysis parameters as a measure of safety
Timeframe: Up to 21 Weeks
Interventions:
Enrollment:
59
Primary completion date:
2016-18-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bonnie C. Shaddinger, Georgios Vlasakakis, Joseph Soffer, Karl M. Thorpe, Daniel Hatch, and Antonio J. Nino.A Randomized, Double-blind, Single-dose, Crossover Study to Demonstrate the Bioequivalence of Two Formulations of Albiglutide in Healthy Adult Participants.Clin Pharmacol Drug Devel.2018;8(3):361-370
DOI: 10.1002/cpdd.606
PubMed ID: 30063297
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
February 2016 to August 2016
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Between 18 and 65 years of age.
- Healthy.
- 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 [%]).
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2016-18-08
Actual study completion date
2016-18-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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