CompletedPhase 1

An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .

An Open-label Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK716155 in Healthy Adult Female Subjects

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-30•Female•Healthy volunteers

Primary endpoint

•AUC0-24 of norethindrone and ethinyl estradiol after OC alone in Period 1 (AUC₀-∞, AUC₀-∞)

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 IDNCT01077505

Org study ID107032

Timeline

Milestones

Study first posted2010-03-01estimated

Study start2010-03-15actual

Primary completion2010-11-24actual

Study completion2010-11-24actual

Last update posted2017-06-14actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Healthy female subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, clinical laboratory tests, and 12-lead ECG;

•Women of childbearing potential must use protocol-defined contraceptive methods;

•BMI is 19 to 30 kg/m2 and body weight ≥50 kg (110 lbs) and <114 kg (<250 lbs);

•Aspartate aminotransferase (AST), ALT, alkaline phosphatase, and bilirubin is </=1.5 × ULN;

Exclusion criteria

•Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG;

•Blood pressure ≥140/90 mm Hg or heart rate >100 beats/minute at Screening;

•Corrected QT (QTc) intervals >450 msec (per ECG machine interpretation);

•Pregnant or nursing females;

•A positive prestudy hepatitis B surface antigen, positive hepatitis C antibody, or HIV result within 3 months of Screening;

•Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);

•Smoking or using any nicotine products, including smoking cessation patches containing any amount of nicotine within the 6 months before Screening;

•Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception;

•Subjects have participated in a clinical trial and have 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);

•History of substance abuse within the past year as determined by the investigator;

•History of alcohol abuse defined as an average weekly intake of >7 drinks;

•Positive urine drug screen at Screening or predose during the Run-in Period and on Day 1 of Periods 1 and 2;

•Use of prescription or nonprescription drugs, vitamins, dietary/herbal supplements including St. John's Wort, nonsteroidal antiinflammatory medications, and aspirin within 14 days or 5 half-lives, whichever is longer prior to the first dose of investigational product;

•Willing to refrain from consuming grapefruit or cranberry products (such as juice, fruit, or nutritional supplements) at any time during participation in the study;

•Donation of blood in excess of 500 mL within 56 days prior to dosing or intention of donating in the month after completing the study;

•History of thyroid dysfunction or an abnormal (i.e., outside normal reference range) thyroid function test assessed by thyroid stimulating hormone (TSH) at Screening;

•History of drug allergy or other allergy, which, in the opinion of the responsible study physician, contradicts the subject's participation;

•History of any condition that would contraindicate OC administration (including hypertension, stroke, ischemic heart disease, venous thromboembolism, carcinoma of the breast, etc.);

•History of type 1 or 2 diabetes mellitus;

•History of migraine if aged >35 years or has focal symptoms associated with migraine;

•Any condition that would affect drug transit time or absorption (e.g., gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, chronic diarrhea, vagotomy, chronic gastroesophageal reflux disease, malabsorption, colostomy, Crohn's disease, ulcerative colitis, or celiac sprue); or

•Previous or current receipt of exenatide or any other GLP 1 agonist;

Endpoints (4)

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 clinical outcomes

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

AUC0-24 of norethindrone and ethinyl estradiol after OC alone in Period 1 and after OC with albiglutide in Period 2.

Time frame:Day 21

AUC₀-∞

concentration, descriptive

componentsAUC₀-∞, AUC₀-∞

Secondary/protocol endpoint

Cmax, Cmin, tmax, and t½ of norethindrone and ethinyl estradiol after OC alone on Day 21 of Period 1 and after OC with albiglutide on Day 21 of Period 2.

Time frame:Day 21 of each period.

concentration, descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Predose serum levels of LH and FSH after OC alone and after OC with albiglutide.

Time frame:Days 1 and 11 through 14 of each period.

concentration, descriptive

Secondary/protocol endpoint

Predose serum levels of progesterone after OC alone and after OC with albiglutide.

Time frame:Day 21 of each period.

concentration, 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.