Drug-drug Interaction of BI 201335 and Microgynon

Phase 1

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: BI 201335

• Registration Number: NCT01570244
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test	BI 201335	multiple doses of Microgynon + BI 201335
Test	levonorgestrel	multiple doses of Microgynon + BI 201335
Reference	Ethinylestradiol	multiple doses of Microgynon
Reference	levonorgestrel	multiple doses of Microgynon
Test	Ethinylestradiol	multiple doses of Microgynon + BI 201335

Primary Outcome Measures

Name	Time	Method
Cmax,ss 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	maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol
C24,ss 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	measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol
AUCt,ss 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	Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Cmax,ss 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	maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel
AUCτ,ss 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	Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel
C24,ss 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	measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Drug Related Adverse Events	from drug administration up to 14 days	number of participants with investigator-defined drug related adverse events
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.	from drug administration up to 14 days	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.

Trial Locations

Locations (1)

1220.56.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany