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Trial record 28 of 28 for:    RNA | BI 201335 OR faldaprevir

Drug-drug Interaction of BI 201335 and Microgynon

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ClinicalTrials.gov Identifier: NCT01570244
Recruitment Status : Completed
First Posted : April 4, 2012
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: levonorgestrel
Drug: Ethinylestradiol
Drug: BI 201335
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description

The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.

Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.

Period 2: Microgynon tablets and Faldaprevir.

Period Title: Microgynon
Started 16
Completed 16
Not Completed 0
Period Title: Microgynon+Faldaprevir
Started 16
Completed 15
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title All Subjects
Hide Arm/Group Description The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
28.4  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
16
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title AUCt,ss of Ethinylestradiol
Hide Description Area under the curve over the dosing interval t under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg*h/mL
1010
(23.5%)
1450
(27.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 140.96
Confidence Interval (2-Sided) 90%
133.84 to 148.47
Parameter Dispersion
Type: Standard Deviation
Value: 8.1
Estimation Comments the standard deviation is actually the geometric coefficient of variation
2.Primary Outcome
Title Cmax,ss of Ethinylestradiol
Hide Description maximum measured concentration over the uniform dosing interval under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
108
(23.6%)
127
(25.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 114.82
Confidence Interval (2-Sided) 90%
105.49 to 124.97
Parameter Dispersion
Type: Standard Deviation
Value: 13.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation
3.Primary Outcome
Title C24,ss of Ethinylestradiol
Hide Description measured concentration of the analyte at the end of dosing interval under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
19.1
(32.9%)
33.2
(42.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 171.37
Confidence Interval (2-Sided) 90%
160.20 to 183.33
Parameter Dispersion
Type: Standard Deviation
Value: 10.5
Estimation Comments the standard deviation is actually the geometric coefficient of variation
4.Primary Outcome
Title AUCτ,ss of Levonorgestrel
Hide Description Area under the curve over the dosing interval τ under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
83.3
(42.0%)
120
(40.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 140.53
Confidence Interval (2-Sided) 90%
136.40 to 144.78
Parameter Dispersion
Type: Standard Deviation
Value: 4.6
Estimation Comments the standard deviation is actually the geometric coefficient of variation
5.Primary Outcome
Title Cmax,ss of Levonorgestrel
Hide Description maximum measured concentration over the uniform dosing interval under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
7.57
(34.9%)
8.95
(33.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 115.28
Confidence Interval (2-Sided) 90%
110.81 to 119.92
Parameter Dispersion
Type: Standard Deviation
Value: 6.1
Estimation Comments the standard deviation is actually the geometric coefficient of variation
6.Primary Outcome
Title C24,ss of Levonorgestrel
Hide Description measured concentration of the analyte at the end of dosing interval under steady state conditions 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2.43
(49.4%)
3.85
(47.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Microgynon, Microgynon + Faldaprevir
Comments relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel
Type of Statistical Test Non-Inferiority or Equivalence
Comments investigation of relative bioavailability (no formal testing)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 153.85
Confidence Interval (2-Sided) 90%
145.99 to 162.14
Parameter Dispersion
Type: Standard Deviation
Value: 8.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation
7.Secondary Outcome
Title Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
Hide Description 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.
Time Frame from drug administration up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment.
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Number of Participants With Drug Related Adverse Events
Hide Description number of participants with investigator-defined drug related adverse events
Time Frame from drug administration up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
treated set
Arm/Group Title Microgynon Microgynon + Faldaprevir
Hide Arm/Group Description:
Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: participants
2 15
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)
Adverse Event Reporting Description During the run-in-period, the volunteers were to be contacted at least twice and asked to report adverse events and concomitant medication. In addition, each volunteer was to be assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
 
Arm/Group Title Microgynon Microgynon + BI 201335
Hide Arm/Group Description Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.

Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning.

All-Cause Mortality
Microgynon Microgynon + BI 201335
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Microgynon Microgynon + BI 201335
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Microgynon Microgynon + BI 201335
Affected / at Risk (%) Affected / at Risk (%)
Total   12/16 (75.00%)   14/16 (87.50%) 
Cardiac disorders     
Tachycardia  1  0/16 (0.00%)  1/16 (6.25%) 
Eye disorders     
Ocular icterus  1  0/16 (0.00%)  6/16 (37.50%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/16 (0.00%)  4/16 (25.00%) 
Abdominal pain upper  1  0/16 (0.00%)  1/16 (6.25%) 
Diarrhoea  1  0/16 (0.00%)  2/16 (12.50%) 
Flatulence  1  0/16 (0.00%)  1/16 (6.25%) 
Haemorrhoids  1  1/16 (6.25%)  0/16 (0.00%) 
Nausea  1  0/16 (0.00%)  8/16 (50.00%) 
Stomatitis  1  0/16 (0.00%)  1/16 (6.25%) 
Vomiting  1  1/16 (6.25%)  4/16 (25.00%) 
General disorders     
Asthenia  1  0/16 (0.00%)  1/16 (6.25%) 
Fatigue  1  0/16 (0.00%)  1/16 (6.25%) 
Oedema peripheral  1  0/16 (0.00%)  1/16 (6.25%) 
Pain  1  0/16 (0.00%)  1/16 (6.25%) 
Swelling  1  1/16 (6.25%)  0/16 (0.00%) 
Infections and infestations     
Oral herpes  1  2/16 (12.50%)  0/16 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  0/16 (0.00%)  1/16 (6.25%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/16 (0.00%)  7/16 (43.75%) 
Increased appetite  1  0/16 (0.00%)  2/16 (12.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/16 (6.25%)  0/16 (0.00%) 
Bone pain  1  1/16 (6.25%)  1/16 (6.25%) 
Muscle tightness  1  0/16 (0.00%)  1/16 (6.25%) 
Myalgia  1  0/16 (0.00%)  1/16 (6.25%) 
Nervous system disorders     
Dizziness  1  1/16 (6.25%)  3/16 (18.75%) 
Dysgeusia  1  0/16 (0.00%)  1/16 (6.25%) 
Headache  1  5/16 (31.25%)  6/16 (37.50%) 
Orthostatic intolerance  1  1/16 (6.25%)  0/16 (0.00%) 
Paraesthesia  1  0/16 (0.00%)  1/16 (6.25%) 
Psychiatric disorders     
Apathy  1  0/16 (0.00%)  2/16 (12.50%) 
Renal and urinary disorders     
Pollakiuria  1  0/16 (0.00%)  1/16 (6.25%) 
Reproductive system and breast disorders     
Metrorrhagia  1  1/16 (6.25%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/16 (6.25%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/16 (0.00%)  1/16 (6.25%) 
Pruritus  1  0/16 (0.00%)  1/16 (6.25%) 
Rash  1  0/16 (0.00%)  1/16 (6.25%) 
Rash papular  1  0/16 (0.00%)  1/16 (6.25%) 
Vascular disorders     
Haematoma  1  0/16 (0.00%)  1/16 (6.25%) 
Hot flush  1  0/16 (0.00%)  3/16 (18.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01570244     History of Changes
Other Study ID Numbers: 1220.56
2011-006061-17 ( EudraCT Number: EudraCT )
First Submitted: April 2, 2012
First Posted: April 4, 2012
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015