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An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide . | Clinical Trials | Clareo Health

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

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

NCT01077505•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

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;
+12 more criteria

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Key Dates

Start Date

March 15, 2010

Primary Completion Date

November 24, 2010

Completion Date

November 24, 2010

Last Updated

June 14, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

albiglutide

BIOLOGICAL

Oral contraceptive (Brevicon)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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