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Trial record 25 of 28 for:    RNA | BI 201335 OR faldaprevir

Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

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ClinicalTrials.gov Identifier: NCT01637922
Recruitment Status : Completed
First Posted : July 11, 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: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Intervention Drug: BI 201335
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methadone Group Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9.

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9.

Period Title: Overall Study
Started 15 19
Completed 13 14
Not Completed 2 5
Reason Not Completed
Adverse Event             0             1
Protocol Violation             0             1
Withdrawal by Subject             0             3
Lost to Follow-up             2             0
Arm/Group Title Methadone Group Buprenorphine/Naloxone (Suboxone) Total
Hide Arm/Group Description

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Total of all reporting groups
Overall Number of Baseline Participants 15 19 34
Hide Baseline Analysis Population Description
This set included all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 19 participants 34 participants
35.4  (11.0) 34.1  (8.7) 34.6  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 19 participants 34 participants
Female
4
  26.7%
3
  15.8%
7
  20.6%
Male
11
  73.3%
16
  84.2%
27
  79.4%
1.Primary Outcome
Title R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng*h/mL]
R-methadone with FDV (Day 9)
6990
(31.7%)
R-methadone alone (Day 1)
5920
(37.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.1638
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 118.12
Confidence Interval (2-Sided) 90%
107.06 to 130.32
Parameter Dispersion
Type: Standard Deviation
Value: 15.4
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
2.Primary Outcome
Title R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng/ml]
R-methadone with FDV (Day 9)
393
(29.8%)
R-methadone alone (Day 1)
345
(33.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0391
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 114.08
Confidence Interval (2-Sided) 90%
104.812 to 124.164
Parameter Dispersion
Type: Standard Deviation
Value: 13.2
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
3.Primary Outcome
Title R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng/mL]
R-methadone with FDV (Day 9)
235
(36.8%)
R-methadone alone (Day 1)
210
(39.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0603
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 111.79
Confidence Interval (2-Sided) 90%
99.243 to 125.922
Parameter Dispersion
Type: Standard Deviation
Value: 18.7
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
4.Primary Outcome
Title S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9
Hide Description These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng*h/ml]
S-methadone with FDV (Day 9)
7610
(39.3%)
S-methadone alone (Day 1)
6470
(41.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.1424
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 117.65
Confidence Interval (2-Sided) 90%
106.89 to 129.50
Parameter Dispersion
Type: Standard Deviation
Value: 15.0
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
5.Primary Outcome
Title S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9
Hide Description These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng/mL]
S-methadone with FDV (Day 9)
474
(36.6%)
S-methadone alone (Day 1)
425
(34.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0367
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 111.46
Confidence Interval (2-Sided) 90%
100.420 to 123.715
Parameter Dispersion
Type: Standard Deviation
Value: 16.3
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
6.Primary Outcome
Title S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9
Hide Description These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Methadone Group
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [ng/mL]
S-methadone with FDV (Day 9)
231
(46.3%)
S-methadone alone (Day 1)
207
(48.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0488
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 111.52
Confidence Interval (2-Sided) 90%
99.577 to 124.888
Parameter Dispersion
Type: Standard Deviation
Value: 17.7
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
7.Primary Outcome
Title Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg*h/ml]
BUPRENORPHINE with FDV (Day 9)
58700
(73.1%)
BUPRENORPHINE alone (Day 1)
54000
(86.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.1642
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 108.71
Confidence Interval (2-Sided) 90%
85.14 to 138.80
Parameter Dispersion
Type: Standard Deviation
Value: 36.1
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
8.Primary Outcome
Title Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/ml]
BUPRENORPHINE with FDV (Day 9)
7610
(74.5%)
BUPRENORPHINE alone (Day 1)
8240
(92.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.1420
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 92.43
Confidence Interval (2-Sided) 90%
73.48 to 116.27
Parameter Dispersion
Type: Standard Deviation
Value: 33.7
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
9.Primary Outcome
Title Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/mL]
BUPRENORPHINE with FDV (Day 9)
1110
(99.0%)
BUPRENORPHINE alone (Day 1)
904
(109%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.1915
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 108.36
Confidence Interval (2-Sided) 90%
81.611 to 143.883
Parameter Dispersion
Type: Standard Deviation
Value: 38.1
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
10.Primary Outcome
Title Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg*h/ml]
NORBUPRENORPHINE with FDV (Day 9)
59200
(93.5%)
NORBUPRENORPHINE alone (Day 1)
42900
(135%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.6889
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 138.00
Confidence Interval (2-Sided) 90%
97.20 to 195.92
Parameter Dispersion
Type: Standard Deviation
Value: 50.7
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
11.Primary Outcome
Title Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/mL]
NORBUPRENORPHINE with FDV (Day 9)
3690
(91.9%)
NORBUPRENORPHINE alone (Day 1)
2770
(126%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.6188
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 132.86
Confidence Interval (2-Sided) 90%
93.32 to 189.16
Parameter Dispersion
Type: Standard Deviation
Value: 51.1
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
12.Primary Outcome
Title Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/mL]
NORBUPRENORPHINE with FDV (Day 9)
2080
(102%)
NORBUPRENORPHINE alone (Day 1)
2010
(113%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.3152
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 112.03
Confidence Interval (2-Sided) 90%
74.85 to 167.67
Parameter Dispersion
Type: Standard Deviation
Value: 52.5
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
13.Primary Outcome
Title Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg*h/ml]
NALOXONE with FDV (Day 9)
971
(69.8%)
NALOXONE alone (Day 1) N=12
1000
(87.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0107
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 98.94
Confidence Interval (2-Sided) 90%
85.810 to 114.076
Parameter Dispersion
Type: Standard Deviation
Value: 19.6
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
14.Primary Outcome
Title Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/mL]
NALOXONE with FDV (Day 9)
284
(107%)
NALOXONE alone (Day 1) N=13
357
(82.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value 0.0738
Comments p-value for ratio outside interval 80% to 125%
Method ANOVA
Comments Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.
Method of Estimation Estimation Parameter Geometric mean ratio (%)
Estimated Value 94.33
Confidence Interval (2-Sided) 90%
78.017 to 114.054
Parameter Dispersion
Type: Standard Deviation
Value: 27.6
Estimation Comments The standard deviation is actually the intra-individual geometric coefficient of variation
15.Primary Outcome
Title Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.
Hide Description These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Time Frame 0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.
Arm/Group Title Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 1
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: [pg/mL]
NALOXONE with FDV (Day 9)
23.4 [1] 
(NA%)
NALOXONE alone (Day 1)
25.6 [2] 
(NA%)
[1]
There was insufficient data to produce an estimate for dispersion. There was only 1 patients for this endpoint.
[2]
There was insufficient data to produce an estimate for dispersion. There was only 1 patient for this endpoint.
16.Secondary Outcome
Title Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline
Hide Description The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.
Time Frame Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug.
Arm/Group Title Methadone Group Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15 19
Median (Full Range)
Unit of Measure: units on a scale
Day 2
0.0
(-1 to 1)
0.0
(-2 to 1)
Day 3
0.0
(-1 to 1)
0.0
(-2 to 1)
Day 4 (N=15,18)
0.0
(-2 to 1)
0.0
(-3 to 1)
Day 5 (N=15,18)
0.0
(-1 to 0)
0.0
(-3 to 1)
Day 6 (N=15,18)
0.0
(-1 to 0)
0.0
(-3 to 2)
Day 7 (N=15,15)
0.0
(-1 to 1)
0.0
(-2 to 1)
Day 8 (N=15,15)
0.0
(-1 to 0)
0.0
(-3 to 1)
Day 9 (N=15,15)
0.0
(-1 to 1)
0.0
(-2 to 2)
Day 10 (N=15,15)
0.0
(-1 to 1)
0.0
(-2 to 1)
Day 11 (N=15,15)
0.0
(-1 to 1)
0.0
(-3 to 0)
Day 12 (N=15,15)
0.0
(-1 to 1)
0.0
(-3 to 1)
End of Treatment (EOT) (N=14,16)
0.0
(-1 to 2)
0.0
(-3 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of trough concentrations of R-methadone and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.01098
Confidence Interval (2-Sided) 95%
-0.189801 to 0.168640
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.10188
Confidence Interval (2-Sided) 95%
-0.287471 to 0.092062
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of trough concentrations of S-methadone and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.03198
Confidence Interval (2-Sided) 95%
-0.209893 to 0.148238
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.00260
Confidence Interval (2-Sided) 95%
-0.189172 to 0.194156
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of Buprenorphine and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.03364
Confidence Interval (2-Sided) 95%
-0.214505 to 0.149733
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.14703
Confidence Interval (2-Sided) 95%
-0.404929 to 0.135425
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of norbuprenorphine and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.05431
Confidence Interval (2-Sided) 95%
-0.240578 to 0.136305
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.09727
Confidence Interval (2-Sided) 95%
-0.344024 to 0.163687
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of naloxone and OOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.36105
Estimation Comments Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.
17.Secondary Outcome
Title Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline
Hide Description The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.
Time Frame Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This set included all subjects who took at least one dose of study drug.
Arm/Group Title Methadone Group Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

Overall Number of Participants Analyzed 15 19
Median (Full Range)
Unit of Measure: units on a scale
Day 2
0.0
(-4 to 2)
-1.0
(-11 to 2)
Day 3
0.0
(-1 to 2)
0.0
(-16 to 9)
Day 4 (N=15,18)
0.0
(-2 to 1)
0.0
(-17 to 3)
Day 5 (N=15,18)
0.0
(-4 to 1)
-0.5
(-21 to 3)
Day 6 (N=15,18)
0.0
(-3 to 1)
-0.5
(-23 to 2)
Day 7 (N=15,15)
0.0
(-2 to 1)
-1.0
(-22 to 4)
Day 8 (N=15,15)
0.0
(-3 to 1)
-1.0
(-24 to 3)
Day 9 (N=15,15)
0.0
(-4 to 1)
-1.0
(-21 to 13)
Day 10 (N=15,15)
0.0
(-4 to 1)
-1.0
(-19 to 4)
Day 11 (N=15,15)
0.0
(-4 to 1)
-1.0
(-23 to 4)
Day 12 (N=15,15)
0.0
(-4 to 1)
-1.0
(-27 to 4)
End of Treatment (EOT) (N=14,16)
0.0
(-4 to 1)
-1.0
(-20 to 3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of trough concentrations of R-methadone and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.04783
Confidence Interval (2-Sided) 95%
-0.132750 to 0.224946
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.39865
Confidence Interval (2-Sided) 95%
-0.547072 to -0.222288
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of trough concentrations of S-methadone and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.11175
Confidence Interval (2-Sided) 95%
-0.069336 to 0.284848
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Methadone Group
Comments Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.16815
Confidence Interval (2-Sided) 95%
-0.347870 to 0.025107
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of Buprenorphine and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.01260
Confidence Interval (2-Sided) 95%
-0.170160 to 0.194417
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.02352
Confidence Interval (2-Sided) 95%
-0.253932 to 0.296960
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of norbuprenorphine and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value -0.05787
Confidence Interval (2-Sided) 95%
-0.243920 to 0.132819
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.04052
Confidence Interval (2-Sided) 95%
-0.218159 to 0.293233
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Buprenorphine/Naloxone (Suboxone)
Comments Pearson correlation of trough concentrations of naloxone and SOWS
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Correlation Coefficient
Estimated Value 0.92231
Estimation Comments Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methadone Group Buprenorphine/Naloxone (Suboxone)
Hide Arm/Group Description

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.

BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9.

All-Cause Mortality
Methadone Group Buprenorphine/Naloxone (Suboxone)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methadone Group Buprenorphine/Naloxone (Suboxone)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methadone Group Buprenorphine/Naloxone (Suboxone)
Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   18/19 (94.74%) 
Blood and lymphatic system disorders     
Thrombocytosis  1  0/15 (0.00%)  1/19 (5.26%) 
Eye disorders     
Conjunctivitis  1  0/15 (0.00%)  1/19 (5.26%) 
Dry eye  1  1/15 (6.67%)  0/19 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/15 (6.67%)  1/19 (5.26%) 
Abdominal pain  1  0/15 (0.00%)  1/19 (5.26%) 
Abdominal pain upper  1  1/15 (6.67%)  1/19 (5.26%) 
Constipation  1  0/15 (0.00%)  1/19 (5.26%) 
Dyspepsia  1  2/15 (13.33%)  0/19 (0.00%) 
Nausea  1  7/15 (46.67%)  10/19 (52.63%) 
Vomiting  1  5/15 (33.33%)  5/19 (26.32%) 
General disorders     
Fatigue  1  0/15 (0.00%)  1/19 (5.26%) 
Hepatobiliary disorders     
Drug-induced liver injury  1  0/15 (0.00%)  1/19 (5.26%) 
Jaundice  1  0/15 (0.00%)  1/19 (5.26%) 
Investigations     
Blood bilirubin increased  1  3/15 (20.00%)  7/19 (36.84%) 
Blood creatine phosphokinase increased  1  0/15 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/15 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Dizziness  1  0/15 (0.00%)  1/19 (5.26%) 
Headache  1  2/15 (13.33%)  2/19 (10.53%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/15 (6.67%)  0/19 (0.00%) 
Erythema  1  0/15 (0.00%)  1/19 (5.26%) 
Pruritus  1  0/15 (0.00%)  1/19 (5.26%) 
Pruritus generalised  1  1/15 (6.67%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
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: NCT01637922     History of Changes
Other Study ID Numbers: 1220.57
First Submitted: July 9, 2012
First Posted: July 11, 2012
Results First Submitted: July 3, 2015
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015