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Trial record 43 of 50 for:    BI 201335 OR faldaprevir

Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01371006
Recruitment Status : Completed
First Posted : June 10, 2011
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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: low dose
Drug: normal dose
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Period Title: Overall Study
Started 14 15
Completed 13 15
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam Total
Hide Arm/Group Description

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
39.4  (10.7) 33.1  (11.6) 36.1  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
8
  57.1%
6
  40.0%
14
  48.3%
Male
6
  42.9%
9
  60.0%
15
  51.7%
1.Primary Outcome
Title Group A - Efavirenz: Cmax
Hide Description Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.
Arm/Group Title 50 mg Efavirenz 50 mg Efavirenz+240 mg Faldaprevir
Hide Arm/Group Description:
single oral administration of 50 mg Efavirenz dosed alone (Day 1)
single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
Overall Number of Participants Analyzed 14 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
771.0
(29.1%)
809.0
(19.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 mg Efavirenz, 50 mg Efavirenz+240 mg Faldaprevir
Comments relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz
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 105.61
Confidence Interval (2-Sided) 90%
90.81 to 122.82
Parameter Dispersion
Type: Standard Deviation
Value: 22.0
Estimation Comments the standard deviation is actually the geometric coefficient of variation
2.Primary Outcome
Title Group A - Efavirenz: AUC0-∞
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group A of the PK set.
Arm/Group Title 50 mg Efavirenz 50 mg Efavirenz+240 mg Faldaprevir
Hide Arm/Group Description:
single oral administration of 50 mg Efavirenz dosed alone (Day 1)
single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
Overall Number of Participants Analyzed 14 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
36100.0
(30.3%)
40700.0
(28.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 mg Efavirenz, 50 mg Efavirenz+240 mg Faldaprevir
Comments relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz
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 116.12
Confidence Interval (2-Sided) 90%
101.87 to 132.35
Parameter Dispersion
Type: Standard Deviation
Value: 18.8
Estimation Comments the standard deviation is actually the geometric coefficient of variation
3.Primary Outcome
Title Group B - Faldaprevir: Cmax,ss
Hide Description Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title 7.5 mg Midazolam+240 mg Faldaprevir 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Hide Arm/Group Description:
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
24000.0
(76.4%)
17200.0
(111%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5 mg Midazolam+240 mg Faldaprevir, 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Comments relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir
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 71.83
Confidence Interval (2-Sided) 90%
61.46 to 83.95
Parameter Dispersion
Type: Standard Deviation
Value: 23.6
Estimation Comments the standard deviation is actually the geometric coefficient of variation
4.Primary Outcome
Title Group B - Faldaprevir: AUC0-12h,ss
Hide Description Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title 7.5 mg Midazolam+240 mg Faldaprevir 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Hide Arm/Group Description:
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
225000.0
(91.1%)
146000.0
(148%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5 mg Midazolam+240 mg Faldaprevir, 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Comments relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir
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 64.97
Confidence Interval (2-Sided) 90%
53.32 to 79.16
Parameter Dispersion
Type: Standard Deviation
Value: 30.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation
5.Primary Outcome
Title Group B - Faldaprevir: C12,ss
Hide Description Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title 7.5 mg Midazolam+240 mg Faldaprevir 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Hide Arm/Group Description:
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
Overall Number of Participants Analyzed 15 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
14700.0
(119.0%)
7650.0
(277.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 7.5 mg Midazolam+240 mg Faldaprevir, 7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz
Comments relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir
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 54.31
Confidence Interval (2-Sided) 90%
40.47 to 72.88
Parameter Dispersion
Type: Standard Deviation
Value: 44.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation
6.Secondary Outcome
Title Group A – Faldaprevir: Cmax,ss
Hide Description Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence group A of the PK set
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
34600.0
(26.0%)
7.Secondary Outcome
Title Group A – Faldaprevir: Tmax,ss
Hide Description Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence sequence group A of the PK set
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
3.00
(2.00 to 4.03)
8.Secondary Outcome
Title Group A – Faldaprevir: AUC0-12h,ss
Hide Description Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence group A of the PK set
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
341000
(27.2%)
9.Secondary Outcome
Title Group A – Faldaprevir: C12,ss
Hide Description Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence group A of the PK set
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
23900
(27.7%)
10.Secondary Outcome
Title Group A - Efavirenz: Tmax
Hide Description Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence group A of the PK set
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: hours
Day 1: Efavirenz
3.00
(1.50 to 4.02)
Day 14: Efavirenz+Faldaprevir (N=13)
3.03
(1.00 to 4.03)
11.Secondary Outcome
Title Group B - Faldaprevir: Tmax,ss
Hide Description Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir
Hide Outcome Measure Data
Hide Analysis Population Description
All patients entered in sequence group B of the PK set
Arm/Group Title Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: hours
Day 9: Midazolam+Faldaprevir
3.00
(0.00 to 4.17)
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
2.02
(1.00 to 4.03)
12.Secondary Outcome
Title Group B - Midazolam: Cmax
Hide Description Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1: Midazolam
110.0
(45.6%)
Day 9: Midazolam+Faldaprevir
121.0
(46.1%)
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
44.9
(101.0%)
13.Secondary Outcome
Title Group B - Midazolam: Tmax
Hide Description Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: hours
Day 1: Midazolam
1.00
(0.50 to 1.50)
Day 9: Midazolam+Faldaprevir
1.00
(0.50 to 3.00)
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
0.74
(0.50 to 3.02)
14.Secondary Outcome
Title Group B - Midazolam: AUC0-∞
Hide Description Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)
Time Frame 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the PK set.
Arm/Group Title Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
Day 1: Midazolam
278
(28.3%)
Day 9: Midazolam+Faldaprevir
624
(54.3%)
Day 18: Midazolam+Faldaprevir+Efavirenz (N=14)
110
(88.1%)
15.Secondary Outcome
Title Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG
Hide Description Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame From first treatment administration (Day 1) up to Day 24
Hide Outcome Measure Data
Hide Analysis Population Description
treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication
Arm/Group Title Group A: 240 mg Faldaprevir+50 mg Efavirenz Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam
Hide Arm/Group Description:

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.

oral administration with water after food intake.

Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.

Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.

oral administration with water after food intake.

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
Weight decreased 1 0
Hepatic enzyme increased 0 1
16.Secondary Outcome
Title Group A - Number of Participants With Drug Related Adverse Events
Hide Description

Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.

AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.

Time Frame From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group A of the treated set.
Arm/Group Title Efavirenz Faldaprevir Efavirenz+Faldaprevir Total On-treatment
Hide Arm/Group Description:
Treatment with single-dose Efavirenz.
During treatment with Faldaprevir.
During treatment with Faldaprevir and single-dose Efavirenz.
Total number of participants with drug related adverse events during treatment.
Overall Number of Participants Analyzed 14 14 13 14
Measure Type: Number
Unit of Measure: participants
2 13 11 13
17.Secondary Outcome
Title Group B - Number of Participants With Drug Related Adverse Events
Hide Description

Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.

AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.

Time Frame From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)
Hide Outcome Measure Data
Hide Analysis Population Description
all subjects entered in sequence group B of the treated set.
Arm/Group Title Midazolam Faldaprevir Faldaprevir+Midazolam Faldaprevir+Midazolam+Efavirenz Total On-treatment
Hide Arm/Group Description:
Treatment with single-dose Midazolam.
During treatment with Faldaprevir.
During treatment with Faldaprevir and single-dose Midazolam.
During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
Total number of participants with drug related adverse events during treatment.
Overall Number of Participants Analyzed 15 15 15 15 15
Measure Type: Number
Unit of Measure: participants
1 14 3 14 15
Time Frame From Day 1 up to 30 days after last treatment. Group A: Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24 Group B: Days 1,2,6,8,9,10,11,14,17,18,19,24
Adverse Event Reporting Description AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone.
 
Arm/Group Title Group A: Efavirenz Group A: Faldaprevir Group A: Faldaprevir+Efavirenz Group B: Midazolam Group B: Faldaprevir Group B: Faldaprevir+Midazolam Group B: Faldaprevir+Midazolam+Efavirenz
Hide Arm/Group Description Treatment with single-dose Efavirenz in Group A. During treatment with Faldaprevir in Group A. During treatment with Faldaprevir and single-dose Efavirenz in Group A. Treatment with single-dose Midazolam in Group B. During treatment with Faldaprevir in Group B. During treatment with Faldaprevir and single-dose Midazolam in Group B. During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
All-Cause Mortality
Group A: Efavirenz Group A: Faldaprevir Group A: Faldaprevir+Efavirenz Group B: Midazolam Group B: Faldaprevir Group B: Faldaprevir+Midazolam Group B: Faldaprevir+Midazolam+Efavirenz
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group A: Efavirenz Group A: Faldaprevir Group A: Faldaprevir+Efavirenz Group B: Midazolam Group B: Faldaprevir Group B: Faldaprevir+Midazolam Group B: Faldaprevir+Midazolam+Efavirenz
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/13 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A: Efavirenz Group A: Faldaprevir Group A: Faldaprevir+Efavirenz Group B: Midazolam Group B: Faldaprevir Group B: Faldaprevir+Midazolam Group B: Faldaprevir+Midazolam+Efavirenz
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/14 (21.43%)   13/14 (92.86%)   11/13 (84.62%)   1/15 (6.67%)   14/15 (93.33%)   6/15 (40.00%)   15/15 (100.00%) 
Eye disorders               
Ocular icterus  1  0/14 (0.00%)  4/14 (28.57%)  0/13 (0.00%)  0/15 (0.00%)  5/15 (33.33%)  1/15 (6.67%)  0/15 (0.00%) 
Conjunctivitis  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Gastrointestinal disorders               
Nausea  1  1/14 (7.14%)  6/14 (42.86%)  3/13 (23.08%)  0/15 (0.00%)  6/15 (40.00%)  1/15 (6.67%)  3/15 (20.00%) 
Diarrhoea  1  1/14 (7.14%)  5/14 (35.71%)  2/13 (15.38%)  1/15 (6.67%)  2/15 (13.33%)  1/15 (6.67%)  1/15 (6.67%) 
Vomiting  1  0/14 (0.00%)  3/14 (21.43%)  0/13 (0.00%)  0/15 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  1/15 (6.67%) 
Dyspepsia  1  0/14 (0.00%)  2/14 (14.29%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Abdominal pain  1  0/14 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  2/15 (13.33%) 
Abdominal pain lower  1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Cheilitis  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Dry mouth  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%) 
Flatulence  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Lip dry  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
General disorders               
Fatigue  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%)  3/15 (20.00%) 
Feeling hot  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  2/15 (13.33%) 
Malaise  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Pyrexia  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Hepatobiliary disorders               
Jaundice  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  6/15 (40.00%)  0/15 (0.00%)  0/15 (0.00%) 
Infections and infestations               
Nasopharyngitis  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Rash pustular  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Injury, poisoning and procedural complications               
Sunburn  1  0/14 (0.00%)  0/14 (0.00%)  4/13 (30.77%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Thermal burn  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Investigations               
Hepatic enzyme increased  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Weight decreased  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Nervous system disorders               
Dizziness  1  0/14 (0.00%)  3/14 (21.43%)  0/13 (0.00%)  0/15 (0.00%)  4/15 (26.67%)  0/15 (0.00%)  10/15 (66.67%) 
Headache  1  2/14 (14.29%)  3/14 (21.43%)  5/13 (38.46%)  0/15 (0.00%)  3/15 (20.00%)  0/15 (0.00%)  3/15 (20.00%) 
Circadian rhythm sleep disorder  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Disturbance in attention  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Dysaesthesia  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Dysgeusia  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Hyperaesthesia  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Paraesthesia  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Psychiatric disorders               
Abnormal dreams  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  4/15 (26.67%) 
Sleep disorder  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  2/15 (13.33%)  0/15 (0.00%)  2/15 (13.33%) 
Hypnagogic hallucination  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Initial insomnia  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Renal and urinary disorders               
Renal pain  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Dyspnoea exertional  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Nasal congestion  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Oropharyngeal pain  1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders               
Rash  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  7/15 (46.67%) 
Rash maculo?papular  1  0/14 (0.00%)  0/14 (0.00%)  2/13 (15.38%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Rash macular  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Rash vesicular  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Blister  1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%) 
Hyperhidrosis  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  2/15 (13.33%) 
Dermatitis contact  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Generalised erythema  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Pruritus  1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.0
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01371006     History of Changes
Other Study ID Numbers: 1220.20
First Submitted: June 9, 2011
First Posted: June 10, 2011
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015