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Completed

NCT Number: NCT01570244

Drug-drug Interaction of BI 201335 and Microgynon

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

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

1220.56.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Levonorgestrel

Drug

multiple doses

Ethinylestradiol

Drug

multiple doses

BI 201335

Drug

multiple doses

Primary outcomes

  1. 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

    Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol

  2. 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

    maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol

  3. 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

    measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol

  4. 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

    Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel

  5. 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

    maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel

  6. 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

    measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel

Secondary outcomes

  1. Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.

    Time frame: 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.

  2. Number of Participants With Drug Related Adverse Events

    Time frame: from drug administration up to 14 days

    number of participants with investigator-defined drug related adverse events

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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