The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females

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

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ethinyl estradiol and levonorgestrel; exenatide
* Drug: ethinyl estradiol and levonorgestrel; exenatide
* Drug: ethinyl estradiol and levonorgestrel; exenatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide/oral contraceptive alone | Drug: ethinyl estradiol and levonorgestrel; exenatide<br>* 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<br>* Other names: AC2993;|
| Experimental: Sequence 2<br>Oral contraceptive 30 minutes after exenatide/oral contraceptive alone/oral contraceptive 1 hour prior to exenatide | Drug: ethinyl estradiol and levonorgestrel; exenatide<br>* 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<br>* Other names: AC2993;|
| Experimental: Sequence 3<br>Oral contraceptive alone/oral contraceptive 1 hour prior to exenatide/oral contraceptive 30 minutes after exenatide | Drug: ethinyl estradiol and levonorgestrel; exenatide<br>* 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<br>* Other names: AC2993;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 
| 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. | Baseline through Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, exenatide, Amylin, Lilly