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Trial record 29 of 50 for:    BI 201335 OR faldaprevir

Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01764945
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: BI 201335 (Reference)
Drug: BI 201335 (Test)
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 40mg Faldaprevir: Sequence Group ADBC 40mg Faldaprevir: Sequence Group BACD 40mg Faldaprevir: Sequence Group CBDA 40mg Faldaprevir: Sequence Group DCAB 120mg Faldaprevir: Sequence Group EHFG 120mg Faldaprevir: Sequence Group FEGH 120mg Faldaprevir: Sequence Group GFHE 120mg Faldaprevir: Sequence Group HGEF
Hide Arm/Group Description

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

Period Title: Overall Study
Started 5 5 5 5 10 8 9 9
Completed 5 4 5 5 10 8 8 9
Not Completed 0 1 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0             1             0
Arm/Group Title 40mg Faldaprevir: Sequence Group ADBC 40mg Faldaprevir: Sequence Group BACD 40mg Faldaprevir: Sequence Group CBDA 40mg Faldaprevir: Sequence Group DCAB 120mg Faldaprevir: Sequence Group EHFG 120mg Faldaprevir: Sequence Group FEGH 120mg Faldaprevir: Sequence Group GFHE 120mg Faldaprevir: Sequence Group HGEF Total
Hide Arm/Group Description

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).

The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).

The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.

Oral administration (under fed conditions, i.e. following a high-fat breakfast).

Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 5 10 8 9 9 56
Hide Baseline Analysis Population Description
This trial was an open-label study consisting of two (40mg and 120mg Faldaprevir) 4-way crossover groups. All subjects were to receive 4 treatments: either treatments A, B, C, and D (20 subjects) or treatments E, F, G, and H (36 subjects). Subjects were randomised to 1 of the 4 treatment sequences for each dose group to be tested in a 1:1:1:1 ratio
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 5 participants 10 participants 8 participants 9 participants 9 participants 56 participants
41.2  (5.3) 39.8  (5.1) 38.0  (10.2) 44.4  (4.2) 33.9  (9.7) 38.6  (9.6) 39.4  (8.1) 34.9  (9.5) 38.1  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 10 participants 8 participants 9 participants 9 participants 56 participants
Female
2
  40.0%
3
  60.0%
2
  40.0%
2
  40.0%
5
  50.0%
4
  50.0%
7
  77.8%
3
  33.3%
28
  50.0%
Male
3
  60.0%
2
  40.0%
3
  60.0%
3
  60.0%
5
  50.0%
4
  50.0%
2
  22.2%
6
  66.7%
28
  50.0%
1.Primary Outcome
Title AUC0-∞
Hide Description

Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.

The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.
Arm/Group Title 40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Hide Arm/Group Description:
40 mg faldaprevir soft gelatine capsule (reference).
40 mg faldaprevir oral solution 1
40 mg faldaprevir oral solution 2
40 mg faldaprevir oral solution 3
120 mg faldaprevir soft gelatine capsule (reference).
120 mg faldaprevir oral solution 1
120 mg faldaprevir oral solution 2
120 mg faldaprevir oral solution 3
Overall Number of Participants Analyzed 19 19 20 18 35 35 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
3960
(32.3%)
3400
(28.5%)
3350
(28.4%)
3420
(30.4%)
15000
(34.5%)
13900
(38.8%)
14500
(38.3%)
14100
(36.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment B
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment B : treatment A).

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 82.58
Confidence Interval (2-Sided) 90%
73.69 to 92.54
Parameter Dispersion
Type: Standard Deviation
Value: 19.7
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment C
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment C : treatment A).

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 83.34
Confidence Interval (2-Sided) 90%
73.65 to 94.30
Parameter Dispersion
Type: Standard Deviation
Value: 22.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment D
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment D : treatment A).

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 83.92
Confidence Interval (2-Sided) 90%
74.69 to 94.28
Parameter Dispersion
Type: Standard Deviation
Value: 19.6
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment F
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment F : treatment E).

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 92.90
Confidence Interval (2-Sided) 90%
88.94 to 97.04
Parameter Dispersion
Type: Standard Deviation
Value: 10.5
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment G
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment G : treatment E).

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 96.37
Confidence Interval (2-Sided) 90%
91.55 to 101.43
Parameter Dispersion
Type: Standard Deviation
Value: 12.7
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment H
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment H : treatment E).

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 94.44
Confidence Interval (2-Sided) 90%
89.88 to 99.24
Parameter Dispersion
Type: Standard Deviation
Value: 12.0
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
2.Primary Outcome
Title Cmax
Hide Description Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Time Frame -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
Hide Outcome Measure Data
Hide Analysis Population Description
PK set.
Arm/Group Title 40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Hide Arm/Group Description:
40 mg faldaprevir soft gelatine capsule (reference).
40 mg faldaprevir oral solution 1
40 mg faldaprevir oral solution 2
40 mg faldaprevir oral solution 3
120 mg faldaprevir soft gelatine capsule (reference).
120 mg faldaprevir oral solution 1
120 mg faldaprevir oral solution 2
120 mg faldaprevir oral solution 3
Overall Number of Participants Analyzed 19 19 20 18 35 35 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
86.4
(36.0%)
65.4
(39.0%)
64.0
(40.4%)
69.7
(28.1%)
625.0
(47.3%)
481.0
(47.1%)
488.0
(52.1%)
485.0
(48.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment B
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment B : treatment A).

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 74.07
Confidence Interval (2-Sided) 90%
65.44 to 83.83
Parameter Dispersion
Type: Standard Deviation
Value: 21.5
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment C
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment C : treatment A).

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 73.23
Confidence Interval (2-Sided) 90%
63.33 to 84.68
Parameter Dispersion
Type: Standard Deviation
Value: 26.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment D
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment D : treatment A).

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 78.76
Confidence Interval (2-Sided) 90%
68.94 to 89.99
Parameter Dispersion
Type: Standard Deviation
Value: 22.7
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment F
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment F : treatment E).

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 78.30
Confidence Interval (2-Sided) 90%
71.42 to 85.84
Parameter Dispersion
Type: Standard Deviation
Value: 22.5
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment G
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment G : treatment E).

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 78.43
Confidence Interval (2-Sided) 90%
69.54 to 88.46
Parameter Dispersion
Type: Standard Deviation
Value: 30.4
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment H
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment H : treatment E).

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 78.09
Confidence Interval (2-Sided) 90%
69.35 to 87.94
Parameter Dispersion
Type: Standard Deviation
Value: 29.4
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
3.Primary Outcome
Title AUC0-tz
Hide Description

Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.

The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame -1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.
Hide Outcome Measure Data
Hide Analysis Population Description
PK set.
Arm/Group Title 40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Hide Arm/Group Description:
40 mg faldaprevir soft gelatine capsule (reference).
40 mg faldaprevir oral solution 1
40 mg faldaprevir oral solution 2
40 mg faldaprevir oral solution 3
120 mg faldaprevir soft gelatine capsule (reference).
120 mg faldaprevir oral solution 1
120 mg faldaprevir oral solution 2
120 mg faldaprevir oral solution 3
Overall Number of Participants Analyzed 19 19 20 18 35 35 36 35
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
3020
(29.4%)
2600
(32.9%)
2520
(38.3%)
2550
(34.3%)
14200
(35.2%)
12900
(39.4%)
13400
(38.0%)
13100
(37.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment B
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment B : treatment A).

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 82.02
Confidence Interval (2-Sided) 90%
75.98 to 88.55
Parameter Dispersion
Type: Standard Deviation
Value: 13.1
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment C
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment C : treatment A).

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 80.93
Confidence Interval (2-Sided) 90%
74.58 to 87.83
Parameter Dispersion
Type: Standard Deviation
Value: 14.5
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 40mg Faldaprevir: Treatment A, 40mg Faldaprevir: Treatment D
Comments

relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment D : treatment A).

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 79.60
Confidence Interval (2-Sided) 90%
74.84 to 84.67
Parameter Dispersion
Type: Standard Deviation
Value: 10.2
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment F
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment F : treatment E).

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 91.59
Confidence Interval (2-Sided) 90%
87.53 to 95.84
Parameter Dispersion
Type: Standard Deviation
Value: 11.0
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment G
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment G : treatment E).

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 94.38
Confidence Interval (2-Sided) 90%
89.76 to 99.24
Parameter Dispersion
Type: Standard Deviation
Value: 12.4
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 120mg Faldaprevir: Treatment E, 120mg Faldaprevir: Treatment H
Comments

relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.

(treatment H : treatment E).

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 92.91
Confidence Interval (2-Sided) 90%
88.42 to 97.63
Parameter Dispersion
Type: Standard Deviation
Value: 12.0
Estimation Comments the standard deviation is actually the geometric coefficient of variation.
Time Frame AEs and concomitant medication will be evaluated continuously from first drug administration until the end-of-study examination (up to 5 weeks). AEs persisting after trial completion must be followed up, until they have normalised.
Adverse Event Reporting Description Subjects were required to report spontaneously any AEs throughout the clinical trial. In addition, each volunteer was 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 40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Hide Arm/Group Description 40 mg faldaprevir soft gelatine capsule (reference). 40 mg faldaprevir oral solution 1. 40 mg faldaprevir oral solution 2. 40 mg faldaprevir oral solution 3. 120 mg faldaprevir soft gelatine capsule (reference). 120 mg faldaprevir oral solution 1. 120 mg faldaprevir oral solution 2. 120 mg faldaprevir oral solution 3.
All-Cause Mortality
40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Affected / at Risk (%) 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
40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/19 (0.00%)   0/35 (0.00%)   0/36 (0.00%)   0/36 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
40mg Faldaprevir: Treatment A 40mg Faldaprevir: Treatment B 40mg Faldaprevir: Treatment C 40mg Faldaprevir: Treatment D 120mg Faldaprevir: Treatment E 120mg Faldaprevir: Treatment F 120mg Faldaprevir: Treatment G 120mg Faldaprevir: Treatment H
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   2/20 (10.00%)   8/20 (40.00%)   6/19 (31.58%)   6/35 (17.14%)   5/36 (13.89%)   7/36 (19.44%)   8/35 (22.86%) 
Gastrointestinal disorders                 
Nausea  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  2/19 (10.53%)  1/35 (2.86%)  1/36 (2.78%)  0/36 (0.00%)  0/35 (0.00%) 
Abdominal pain  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  0/35 (0.00%)  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%) 
Diarrhoea  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  1/35 (2.86%)  0/36 (0.00%)  1/36 (2.78%)  1/35 (2.86%) 
Vomiting  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  1/35 (2.86%)  1/36 (2.78%)  0/36 (0.00%)  0/35 (0.00%) 
Infections and infestations                 
Oral herpes  1  0/19 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/19 (0.00%)  0/35 (0.00%)  0/36 (0.00%)  2/36 (5.56%)  1/35 (2.86%) 
Influenza  1  1/19 (5.26%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%)  0/35 (0.00%)  1/36 (2.78%)  0/36 (0.00%)  1/35 (2.86%) 
Rhinitis  1  0/19 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  1/19 (5.26%)  1/35 (2.86%)  0/36 (0.00%)  3/36 (8.33%)  0/35 (0.00%) 
Nasopharyngitis  1  0/19 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/19 (0.00%)  4/35 (11.43%)  0/36 (0.00%)  1/36 (2.78%)  1/35 (2.86%) 
Nervous system disorders                 
Headache  1  1/19 (5.26%)  0/20 (0.00%)  4/20 (20.00%)  1/19 (5.26%)  1/35 (2.86%)  3/36 (8.33%)  4/36 (11.11%)  4/35 (11.43%) 
Renal and urinary disorders                 
Urine odour abnormal  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  0/35 (0.00%)  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%) 
Reproductive system and breast disorders                 
Dysmenorrhoea  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  0/35 (0.00%)  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  2/19 (10.53%)  0/35 (0.00%)  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%) 
Oropharyngeal pain  1  0/19 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/19 (5.26%)  1/35 (2.86%)  0/36 (0.00%)  0/36 (0.00%)  1/35 (2.86%) 
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01764945     History of Changes
Other Study ID Numbers: 1220.46
2012-000687-22 ( EudraCT Number: EudraCT )
First Submitted: January 8, 2013
First Posted: January 10, 2013
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015