DelfaGLP-1 Atlas

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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

1

Recruiting sites

—

Enrollment

16

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI ≤30•Male•Healthy volunteers

Primary endpoint

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

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 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

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

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
1
Other (unclassified)
1

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.