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The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

ethinyl estradiol and levonorgestrel; exenatide

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, exenatide, Amylin, Lilly

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Pre-menopausal female of child-bearing potential. Body Mass Index (BMI) between 19 and 35 kg/m^2, inclusive. Exclusion Criteria: On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study. Evidence of diabetes mellitus. Participation in a study involving administration of an investigational compound within the past 3 months.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Arm Description

Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone

Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide

Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide

Outcomes

Primary Outcome Measures

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.

Secondary Outcome Measures

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

To evaluate the effect of exenatide on the single-dose pharmacokinetics of the combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.

Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.

Assessment of the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive by incidence of adverse events, Adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram (ECG), blood glucose, body weight, physical examination and exenatide antibodies.

Full Information

NCT ID

NCT00254800

First Posted

November 15, 2005

Last Updated

August 17, 2015

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00254800

Brief Title

The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

Official Title

The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

diabetes, exenatide, Amylin, Lilly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide

Intervention Type

Drug

Intervention Name(s)

ethinyl estradiol and levonorgestrel; exenatide

Other Intervention Name(s)

Byetta, AC2993

Intervention Description

Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily

Intervention Type

Drug

Intervention Name(s)

ethinyl estradiol and levonorgestrel; exenatide

Other Intervention Name(s)

Byetta, AC2993

Intervention Description

Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily

Intervention Type

Drug

Intervention Name(s)

ethinyl estradiol and levonorgestrel; exenatide

Other Intervention Name(s)

Byetta, AC2993

Intervention Description

Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily

Primary Outcome Measure Information:

Title

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Description

To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.

Time Frame

Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48

Secondary Outcome Measure Information:

Title

Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax

Description

To evaluate the effect of exenatide on the single-dose pharmacokinetics of the combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose.

Time Frame

Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48

Title

Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies.

Description

Time Frame

Baseline through Day 84

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Malone, MD

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Plymouth

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22429273

Citation

Kothare PA, Seger ME, Northrup J, Mace K, Mitchell MI, Linnebjerg H. Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial. BMC Clin Pharmacol. 2012 Mar 19;12:8. doi: 10.1186/1472-6904-12-8.

Results Reference

derived

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The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

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