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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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study will be an open-label study to evaluate the effect of albiglutide on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Biological: albiglutide Drug: Oral contraceptive (Brevicon) Phase 1

Detailed Description:
This study will be an open-label study in at least one center to evaluate the effect of albiglutide administration on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: albiglutide
albiglutide 50mg weekly
Biological: albiglutide
albiglutide 50mg weekly subcutaneous injection

Drug: Oral contraceptive (Brevicon)
Oral contraceptive (Brevicon)




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Predose serum levels of progesterone after OC alone and after OC with albiglutide. [ Time Frame: Day 21 of each period. ]


Information from the National Library of Medicine

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

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;

Information from the National Library of Medicine

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


Locations
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United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107032
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107032
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):
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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.
Keywords provided by GlaxoSmithKline:
pharmacokinetics
GSK716155
Brevicon
albiglutide
healthy female volunteers
oral contraceptive
Additional relevant MeSH terms:
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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