Drug-drug Interaction of BI 201335 and Microgynon

NCT01570244 | Completed Phase 1 Results

• 2 other identifiers: 1220.562011-006061-17
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (6)

• AUCt,ss of Ethinylestradiol

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

• Cmax,ss of Ethinylestradiol

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

• C24,ss of Ethinylestradiol

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

• AUCτ,ss of Levonorgestrel

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

• Cmax,ss of Levonorgestrel

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

• C24,ss of Levonorgestrel

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

Secondary Outcomes (2)

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

  from drug administration up to 14 days

• Number of Participants With Drug Related Adverse Events

  from drug administration up to 14 days

Study Arms (2)

Reference

EXPERIMENTAL

multiple doses of Microgynon

Drug: levonorgestrel; Drug: Ethinylestradiol

Test

ACTIVE COMPARATOR

multiple doses of Microgynon + BI 201335

Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: BI 201335

Interventions

levonorgestrel DRUG

multiple doses

Test

Ethinylestradiol DRUG

multiple doses

Test

BI 201335 DRUG

multiple doses

Test

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy female subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1220.56.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

• Sabo JP, Lang B, Elgadi M, Huang F. Effect of the hepatitis C virus protease inhibitor faldaprevir on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel in healthy female volunteers. Antimicrob Agents Chemother. 2015 Jan;59(1):514-9. doi: 10.1128/AAC.03589-14. Epub 2014 Nov 10.

  PMID: 25385099 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Levonorgestrel; Ethinyl Estradiol; faldaprevir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 3, 2015
• Results First Posted: August 3, 2015

Record last verified: 2015-07

Locations

DE (1)