Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: faldaprevir; Drug: Microgynon®; Drug: BI 207127

• Registration Number: NCT01941615
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Study Start: 2013-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2016-01-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Results First Posted: 2016-04-11
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 207127 + faldaprevir + Microgynon	Microgynon®	Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127
BI 207127 + faldaprevir + Microgynon	BI 207127	Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127
BI 207127 + faldaprevir + Microgynon	faldaprevir	Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127

Primary Outcome Measures

Name	Time	Method
AUCtau,ss of Levonogestrel	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.
AUCtau,ss of Ethinylestradiol	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
C24,ss of Ethinylestradiol	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.
Cmax,ss of Levonogestrel	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.
C24,ss of Levonogestrel	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.
Cmax,ss of Ethinylestradiol	Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives	Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t

Trial Locations

Locations (1)

1241.31.2 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany