NCT01941615

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 11, 2016

Completed
Last Updated

April 11, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

September 10, 2013

Results QC Date

January 21, 2016

Last Update Submit

March 16, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • AUCtau,ss of Ethinylestradiol

    Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).

    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

  • Cmax,ss of Ethinylestradiol

    Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t

    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

  • C24,ss of Ethinylestradiol

    Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.

    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

  • AUCtau,ss of Levonogestrel

    Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.

    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

  • Cmax,ss of Levonogestrel

    Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.

    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

  • C24,ss of Levonogestrel

    Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.

    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

Study Arms (1)

BI 207127 + faldaprevir + Microgynon

EXPERIMENTAL

Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127

Drug: faldaprevirDrug: Microgynon®Drug: BI 207127

Interventions

faldaprevirDRUG

oral doses for 10 days (period B)

BI 207127 + faldaprevir + Microgynon
Microgynon®DRUG

oral doses for 23 days (period A+B)

BI 207127 + faldaprevir + Microgynon
BI 207127DRUG

oral doses for 10 days (period B)

BI 207127 + faldaprevir + Microgynon

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female subjects
  • Age 18 to 35 years (inclusive)
  • Body Mass Index 20-29.9 kg/m2
  • Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants)

You may not qualify if:

  • Any relevant deviation from healthy conditions
  • Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation
  • Any relevant finding of the gynaecological examination
  • Thrombotic predisposition according to thrombophilic testing
  • Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
  • Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.
  • Relevant varicosis
  • No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner).
  • Use of hormone-containing intrauterine device, depot injection or contraceptive implants
  • Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)
  • AST (aspartate transaminase) and/or ALT (alanine transaminase) \> 1.5 ULN (upper limit of normal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1241.31.2 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Interventions

faldaprevirethinyl estradiol, levonorgestrel drug combinationdeleobuvir

Limitations and Caveats

This trial was prematurely discontinued during the run-in period. During the run-in period, subjects were to receive Microgynon® once daily for 21 to 49 days. The investigational products Deleobuvir + faldaprevir were not administered.

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
+1 800 243 0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 11, 2016

Results First Posted

April 11, 2016

Record last verified: 2016-03

Locations

DE(1)