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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000687-22 | EudraCT Number | EudraCT |
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The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 BI 201335 | Experimental | low dose |
|
| 2 BI 201335 | Experimental | high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 (Reference) | Drug | soft gelatine capsule, oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | 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. | -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. |
| Cmax | Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -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. |
| AUC0-tz | 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. | -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. |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.46.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 40mg Faldaprevir: Sequence Group ADBC | 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). |
| FG001 | 40mg Faldaprevir: Sequence Group BACD | 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). |
| FG002 | 40mg Faldaprevir: Sequence Group CBDA | 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). |
| FG003 | 40mg Faldaprevir: Sequence Group DCAB | 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). |
| FG004 | 120mg Faldaprevir: Sequence Group EHFG | 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). |
| FG005 | 120mg Faldaprevir: Sequence Group FEGH | 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). |
| FG006 | 120mg Faldaprevir: Sequence Group GFHE | 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). |
| FG007 | 120mg Faldaprevir: Sequence Group HGEF | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 40mg Faldaprevir: Sequence Group ADBC | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-∞ | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -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. |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40mg Faldaprevir: Treatment A | 40 mg faldaprevir soft gelatine capsule (reference). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral herpes | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
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| BI 201335 (Test) |
| Drug |
oral solution 3 |
|
| BI 201335 (Test) | Drug | oral solution 3 |
|
| BI 201335 (Test) | Drug | oral solution 2 |
|
| BI 201335 (Reference) | Drug | soft gelatine capsule, oral administration |
|
| BI 201335 (Test) | Drug | oral solution 1 |
|
| BI 201335 (Test) | Drug | oral solution 1 |
|
| BI 201335 (Test) | Drug | oral solution 2 |
|
| BG001 | 40mg Faldaprevir: Sequence Group BACD | 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). |
| BG002 | 40mg Faldaprevir: Sequence Group CBDA | 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). |
| BG003 | 40mg Faldaprevir: Sequence Group DCAB | 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). |
| BG004 | 120mg Faldaprevir: Sequence Group EHFG | 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). |
| BG005 | 120mg Faldaprevir: Sequence Group FEGH | 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). |
| BG006 | 120mg Faldaprevir: Sequence Group GFHE | 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). |
| BG007 | 120mg Faldaprevir: Sequence Group HGEF | 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). |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 40mg Faldaprevir: Treatment B |
40 mg faldaprevir oral solution 1 |
| OG002 | 40mg Faldaprevir: Treatment C | 40 mg faldaprevir oral solution 2 |
| OG003 | 40mg Faldaprevir: Treatment D | 40 mg faldaprevir oral solution 3 |
| OG004 | 120mg Faldaprevir: Treatment E | 120 mg faldaprevir soft gelatine capsule (reference). |
| OG005 | 120mg Faldaprevir: Treatment F | 120 mg faldaprevir oral solution 1 |
| OG006 | 120mg Faldaprevir: Treatment G | 120 mg faldaprevir oral solution 2 |
| OG007 | 120mg Faldaprevir: Treatment H | 120 mg faldaprevir oral solution 3 |
|
|
|
| Primary | Cmax | Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -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. |
|
|
|
|
| Primary | AUC0-tz | 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. | PK set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -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. |
|
|
|
|
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | 40mg Faldaprevir: Treatment B | 40 mg faldaprevir oral solution 1. | 0 | 20 | 2 | 20 |
| EG002 | 40mg Faldaprevir: Treatment C | 40 mg faldaprevir oral solution 2. | 0 | 20 | 8 | 20 |
| EG003 | 40mg Faldaprevir: Treatment D | 40 mg faldaprevir oral solution 3. | 0 | 19 | 6 | 19 |
| EG004 | 120mg Faldaprevir: Treatment E | 120 mg faldaprevir soft gelatine capsule (reference). | 0 | 35 | 6 | 35 |
| EG005 | 120mg Faldaprevir: Treatment F | 120 mg faldaprevir oral solution 1. | 0 | 36 | 5 | 36 |
| EG006 | 120mg Faldaprevir: Treatment G | 120 mg faldaprevir oral solution 2. | 0 | 36 | 7 | 36 |
| EG007 | 120mg Faldaprevir: Treatment H | 120 mg faldaprevir oral solution 3. | 0 | 35 | 8 | 35 |
| Influenza | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MEDDRA 15.1 | Systematic Assessment |
|
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.
| relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment C : treatment A). | ANOVA | Geometric Mean Ratio | 73.23 | Standard Deviation | 26.2 | 2-Sided | 90 | 63.33 | 84.68 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment D : treatment A). | ANOVA | Geometric Mean Ratio | 78.76 | Standard Deviation | 22.7 | 2-Sided | 90 | 68.94 | 89.99 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment F : treatment E). | ANOVA | Geometric Mean Ratio | 78.30 | Standard Deviation | 22.5 | 2-Sided | 90 | 71.42 | 85.84 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment G : treatment E). | ANOVA | Geometric Mean Ratio | 78.43 | Standard Deviation | 30.4 | 2-Sided | 90 | 69.54 | 88.46 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment H : treatment E). | ANOVA | Geometric Mean Ratio | 78.09 | Standard Deviation | 29.4 | 2-Sided | 90 | 69.35 | 87.94 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment C : treatment A). | ANOVA | Geometric Mean Ratio | 80.93 | Standard Deviation | 14.5 | 2-Sided | 90 | 74.58 | 87.83 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment D : treatment A). | ANOVA | Geometric Mean Ratio | 79.60 | Standard Deviation | 10.2 | 2-Sided | 90 | 74.84 | 84.67 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment F : treatment E). | ANOVA | Geometric Mean Ratio | 91.59 | Standard Deviation | 11.0 | 2-Sided | 90 | 87.53 | 95.84 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment G : treatment E). | ANOVA | Geometric Mean Ratio | 94.38 | Standard Deviation | 12.4 | 2-Sided | 90 | 89.76 | 99.24 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |
| relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution. (treatment H : treatment E). | ANOVA | Geometric Mean Ratio | 92.91 | Standard Deviation | 12.0 | 2-Sided | 90 | 88.42 | 97.63 | the standard deviation is actually the geometric coefficient of variation. | Yes | Non-Inferiority or Equivalence | investigation of relative bioavailability (no formal testing). |