CompletedPhase 1

A Drug Interaction Study With Albiglutide and Warfarin

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI ≤30•Male•Healthy volunteers

Primary endpoint

•Pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers (AUC₀-∞, Cmax)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01147731

Org study ID111681

Timeline

Milestones

Study start2010-06-04actual

Study first posted2010-06-22estimated

Primary completion2010-09-09actual

Study completion2010-09-09actual

Last update posted2017-06-22actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•male healthy volunteers in good health

•no clinically significant diseases or clinically significant abnormal laboratory values

•body mass index (BMI) is >/=18 kg and ≤30 kg/m2

•nonsmoker

Exclusion criteria

•positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

•any clinically relevant abnormality

•history of any anaphylactic reaction to any drug

•history of significant cardiovascular or pulmonary dysfunction

•history of excessive bleeding

•current or chronic history of liver disease

•history of alcohol or substance abuse

•history of thyroid disease or dysfunction

•history of gastrointestinal surgery or disease

•history of pancreatitis

•previously received any GLP-1 mimetic compound (e.g., exenatide)

Endpoints (2)

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

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide

Time frame:52 days

AUC₀-∞

concentration, descriptive

componentsAUC₀-∞, Cmax

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).

Time frame:52 days

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Clinical pharmacology of albiglutide, a GLP-1 receptor agonist.
Postgraduate medicine2014 Nov (month)PMID25387217doi:10.3810/pgm.2014.11.2836via clinicaltrials gov reference derived + pubmed nct search
Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive.
Postgraduate medicine2012 Nov (month)PMID23322139doi:10.3810/pgm.2012.11.2613via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.