Drug-drug Interaction of BI 201335 and Microgynon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01570244
First received: April 2, 2012
Last updated: July 3, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: levonorgestrel
Drug: Ethinylestradiol
Drug: BI 201335
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • AUCt,ss of Ethinylestradiol [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol

  • Cmax,ss of Ethinylestradiol [ Time Frame: 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 ] [ Designated as safety issue: No ]
    maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol

  • C24,ss of Ethinylestradiol [ Time Frame: 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 ] [ Designated as safety issue: No ]
    measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol

  • AUCτ,ss of Levonorgestrel [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel

  • Cmax,ss of Levonorgestrel [ Time Frame: 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 ] [ Designated as safety issue: No ]
    maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel

  • C24,ss of Levonorgestrel [ Time Frame: 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 ] [ Designated as safety issue: No ]
    measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel


Secondary Outcome Measures:
  • Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. [ Time Frame: from drug administration up to 14 days ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Drug Related Adverse Events [ Time Frame: from drug administration up to 14 days ] [ Designated as safety issue: No ]
    number of participants with investigator-defined drug related adverse events


Enrollment: 16
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
multiple doses of Microgynon
Drug: levonorgestrel
multiple doses
Drug: Ethinylestradiol
multiple doses
Active Comparator: Test
multiple doses of Microgynon + BI 201335
Drug: levonorgestrel
multiple doses
Drug: Ethinylestradiol
multiple doses
Drug: BI 201335
multiple doses

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570244

Locations
Germany
1220.56.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01570244     History of Changes
Other Study ID Numbers: 1220.56, 2011-006061-17
Study First Received: April 2, 2012
Results First Received: July 3, 2015
Last Updated: July 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Ethinyl Estradiol
Levonorgestrel
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015