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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077505
First received: February 25, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy Female Volunteers
Diabetes Mellitus, Type 2
Biological: albiglutide
Drug: Oral contraceptive (Brevicon)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With Albiglutide in Healthy Adult Female Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Predose serum levels of progesterone after OC alone and after OC with albiglutide. [ Time Frame: Day 21 of each period. ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide
albiglutide 50mg weekly
Biological: albiglutide
albiglutide 50mg weekly subcutaneous injection
Drug: Oral contraceptive (Brevicon)
Oral contraceptive (Brevicon)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077505

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01077505     History of Changes
Other Study ID Numbers: 107032
Study First Received: February 25, 2010
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacokinetics
GSK716155
Brevicon
albiglutide
healthy female volunteers
oral contraceptive

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Albiglutide
Contraceptive Agents
Contraceptives, Oral
Ethynylestradiol mixture with norethindrone
Norinyl
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014