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

NCT ID: NCT01077505

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-15
• Study Completion Date: 2010-11-24

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

albiglutide

albiglutide 50mg weekly

Group Type: EXPERIMENTAL

albiglutide

Intervention Type: BIOLOGICAL

albiglutide 50mg weekly subcutaneous injection

Oral contraceptive (Brevicon)

Intervention Type: DRUG

Oral contraceptive (Brevicon)

Interventions

albiglutide

albiglutide 50mg weekly subcutaneous injection

Intervention Type: BIOLOGICAL

Oral contraceptive (Brevicon)

Oral contraceptive (Brevicon)

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23322139 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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

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Document Type: Informed Consent Form

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

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Document Type: Study Protocol

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

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Document Type: Annotated Case Report Form

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

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Document Type: Clinical Study Report

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

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Document Type: Statistical Analysis Plan

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

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Document Type: Dataset Specification

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

View Document

Related Links

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Other Identifiers

107032

Identifier Type: -

Identifier Source: org_study_id