An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
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ClinicalTrials.gov Identifier: NCT01077505 |
Recruitment Status :
Completed
First Posted : March 1, 2010
Last Update Posted : June 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Biological: albiglutide Drug: Oral contraceptive (Brevicon) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | March 15, 2010 |
Actual Primary Completion Date : | November 24, 2010 |
Actual Study Completion Date : | November 24, 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: albiglutide
albiglutide 50mg weekly
|
Biological: albiglutide
albiglutide 50mg weekly subcutaneous injection Drug: Oral contraceptive (Brevicon) Oral contraceptive (Brevicon) |
- 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 ]
- 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. ]
- 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. ]
- Predose serum levels of progesterone after OC alone and after OC with albiglutide. [ Time Frame: Day 21 of each period. ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077505
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78744 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01077505 |
Other Study ID Numbers: |
107032 |
First Posted: | March 1, 2010 Key Record Dates |
Last Update Posted: | June 14, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
pharmacokinetics GSK716155 Brevicon |
albiglutide healthy female volunteers oral contraceptive |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Contraceptive Agents Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination Contraceptives, Oral rGLP-1 protein Reproductive Control Agents |
Physiological Effects of Drugs Contraceptive Agents, Female Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Combined Contraceptives, Oral, Hormonal Contraceptive Agents, Hormonal Contraceptives, Oral, Sequential Contraceptives, Oral, Synthetic |