Hepatitis C, ChronicPhase 1NCT01570244

Drug-drug Interaction of BI 201335 and Microgynon

A Phase 1 study testing levonorgestrel, Ethinylestradiol and BI 201335 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: levonorgestrel, Ethinylestradiol and BI 201335
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: Apr 2012to Aug 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1220.56.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

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

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
Being tested: levonorgestrel, Ethinylestradiol, BI 201335
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

levonorgestrelDrug
multiple doses
EthinylestradiolDrug
multiple doses
levonorgestrelDrug
multiple doses
BI 201335Drug
multiple doses
EthinylestradiolDrug
multiple doses

Study groups in NCT01570244
Study group	Role	What they receive
Reference	Experimental	multiple doses of Microgynon Receives: Drug: levonorgestrel; Drug: Ethinylestradiol
Test	Active comparator	multiple doses of Microgynon + BI 201335 Receives: Drug: levonorgestrel; Drug: Ethinylestradiol; Drug: BI 201335

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCt,ss of Ethinylestradiol
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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.
Measured: from drug administration up to 14 days
Number of Participants With Drug Related Adverse Events
number of participants with investigator-defined drug related adverse events
Measured: from drug administration up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Aug 2012

First posted4 Apr 2012 (estimated)
Study startApr 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01570244
Sponsor's protocol ID: 1220.56
Other IDs: 2011-006061-17
Status last verified: Jul 2015
First submitted: 2 Apr 2012
Last updated: 3 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25385099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01570244
Acronym / sponsor ID: 1220.56
Conditions: Hepatitis C, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 4 Apr 2012 (estimated)
Results: Posted 3 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reference	Experimental	Drug: levonorgestrel, Drug: Ethinylestradiolmultiple doses of Microgynon
Test	Active comparator	Drug: levonorgestrel, Drug: Ethinylestradiol, Drug: BI 201335multiple doses of Microgynon + BI 201335

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy female subjects

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
levonorgestrelmultiple doses	Drug	Test
Ethinylestradiolmultiple doses	Drug	Test
levonorgestrelmultiple doses	Drug	Reference
BI 201335multiple doses	Drug	Test
Ethinylestradiolmultiple doses	Drug	Reference

Primary outcome

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
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
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
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
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
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

2 secondary outcomes

Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
Time frame: from drug administration up to 14 days
Number of Participants With Drug Related Adverse Events
Time frame: from drug administration up to 14 days

Results and safety

Results posted to the registry on 3 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	16	16

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: pg*h/mL

Measure	Microgynon n = 16	Microgynon + Faldaprevir n = 15
Value	1010 (23.5)	1450 (27.8)

Microgynon vs Microgynon + Faldaprevir: Geometric Mean Ratio: 140.96 (90% CI 133.84 to 148.47), ANOVA

Population analysed: Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Microgynon n = 16	Microgynon + Faldaprevir n = 15
Value	108 (23.6)	127 (25.1)

Microgynon vs Microgynon + Faldaprevir: Odds Ratio (OR): 114.82 (90% CI 105.49 to 124.97), ANOVA

Population analysed: PK set

Primary outcome: C24,ss of Ethinylestradiol

Measure	Microgynon n = 16	Microgynon + Faldaprevir n = 15
Value	19.1 (32.9)	33.2 (42.9)

Microgynon vs Microgynon + Faldaprevir: Geometric Mean Ratio: 171.37 (90% CI 160.20 to 183.33), ANOVA

Population analysed: PK set

Primary outcome: AUCτ,ss of Levonorgestrel

Measure	Microgynon n = 16	Microgynon + Faldaprevir n = 15
Value	83.3 (42.0)	120 (40.6)

Microgynon vs Microgynon + Faldaprevir: Geometric mean ratio: 140.53 (90% CI 136.40 to 144.78), ANOVA

Population analysed: PK set

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from the time the subject signed the informed consent (56 to 28 days before drug administration) through the observational phase until the end-of-study examination (6 to 14 days after the end of period 2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microgynon	0 of 16 (0%)	12 of 16 (75%)	Not reported
Microgynon + BI 201335	0 of 16 (0%)	14 of 16 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25385099Sabo 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.
Related InfoLink provided by the sponsor.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing levonorgestrel, Ethinylestradiol and BI 201335 in people with Hepatitis C, Chronic, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01570244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.