Drug-drug Interaction of BI 201335 and Microgynon

Study Overview
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Brief Summary
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This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel

Official Title
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An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: levonorgestrel
* Drug: Ethinylestradiol
* Drug: levonorgestrel
* Drug: BI 201335
* Drug: Ethinylestradiol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1. Healthy female subjects Exclusion criteria: 1. Any relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reference<br>multiple doses of Microgynon | Drug: levonorgestrel<br>* multiple doses<br>Drug: Ethinylestradiol<br>* multiple doses<br>|
| Active Comparator: Test<br>multiple doses of Microgynon + BI 201335 | Drug: levonorgestrel<br>* multiple doses<br>Drug: Ethinylestradiol<br>* multiple doses<br>Drug: BI 201335<br>* multiple doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt,ss of Ethinylestradiol | Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration | 
| Cmax,ss of Ethinylestradiol | maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration | 
| C24,ss of Ethinylestradiol | measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration | 
| AUCτ,ss of Levonorgestrel | Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration | 
| Cmax,ss of Levonorgestrel | maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration | 
| C24,ss of Levonorgestrel | measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel | on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. | Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | from drug administration up to 14 days | 
| Number of Participants With Drug Related Adverse Events | number of participants with investigator-defined drug related adverse events | from drug administration up to 14 days |