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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Austin, Texas, United States, 78744
- GSK Investigational Site
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: albiglutide
albiglutide 50mg weekly
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albiglutide 50mg weekly subcutaneous injection
Oral contraceptive (Brevicon)
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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Day 21
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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Day 21 of each period.
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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.
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Days 1 and 11 through 14 of each period.
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Predose serum levels of progesterone after OC alone and after OC with albiglutide.
Time Frame: Day 21 of each period.
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Day 21 of each period.
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
- Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Contraceptive Agents, Hormonal
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptive Agents, Female
- Incretins
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Oral, Sequential
- Contraceptive Agents
- Contraceptives, Oral
- rGLP-1 protein
- Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Other Study ID Numbers
Other Study ID Numbers
- 107032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Individual Participant Data Set
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 107032Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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