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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

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE March 1, 2010
Last Update Posted Date June 14, 2017
Actual Study Start Date  ICMJE March 15, 2010
Actual Primary Completion Date November 24, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Biological: albiglutide
    albiglutide 50mg weekly subcutaneous injection
  • Drug: Oral contraceptive (Brevicon)
    Oral contraceptive (Brevicon)
Study Arms  ICMJE Experimental: albiglutide
albiglutide 50mg weekly
Interventions:
  • Biological: albiglutide
  • Drug: Oral contraceptive (Brevicon)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2011)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2010)
20
Actual Study Completion Date  ICMJE November 24, 2010
Actual Primary Completion Date November 24, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077505
Other Study ID Numbers  ICMJE 107032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP