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

NCT01077505 | Completed Phase 1 DMC

• 1 other identifier: 107032
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacokinetics; GSK716155; Brevicon; albiglutide; healthy female volunteers; oral contraceptive

Outcome Measures

Primary Outcomes (1)

• AUC0-24 of norethindrone and ethinyl estradiol after OC alone in Period 1 and after OC with albiglutide in Period 2.

  Day 21

Secondary Outcomes (3)

• 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.

  Day 21 of each period.

• Predose serum levels of LH and FSH after OC alone and after OC with albiglutide.

  Days 1 and 11 through 14 of each period.

• Predose serum levels of progesterone after OC alone and after OC with albiglutide.

  Day 21 of each period.

Study Arms (1)

albiglutide

EXPERIMENTAL

albiglutide 50mg weekly

Biological: albiglutide; Drug: Oral contraceptive (Brevicon)

Interventions

albiglutide BIOLOGICAL

albiglutide 50mg weekly subcutaneous injection

albiglutide

Oral contraceptive (Brevicon) DRUG

Oral contraceptive (Brevicon)

albiglutide

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Publications (2)

• 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.

  PMID: 23322139 BACKGROUND

• 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.

  PMID: 25387217 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 107032 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rGLP-1 protein; Contraceptives, Oral; norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: March 15, 2010
• Primary Completion: November 24, 2010
• Study Completion: November 24, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)