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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002741-11 | EudraCT Number | EudraCT |
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The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 + Faldaprevir | Experimental | Tablets/capsules |
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| Moxifloxacin (Avalox®) | Active Comparator | Tablets |
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| BI 207127 placebo + Faldaprevir placebo | Experimental | Tablets/capsules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127 | Drug | Medium dose oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values. | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment | Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values. |
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Inclusion criteria:
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 |
|---|---|---|---|---|---|---|
| 1241.40.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
After an initial screening (Visit 1) within Day -23 and Day -3 prior of the first treatment period, subjects meeting all inclusion and none of the exclusion criteria participated in Visits 2 to 5.
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| ID | Title | Description |
|---|---|---|
| FG000 | T/R1/R2 | Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| BI 207127 placebo |
| Drug |
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| Faldaprevir placebo | Drug |
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| Faldaprevir | Drug | Medium dose oral administration |
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| Moxifloxacin (Avalox®) | Drug |
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| 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1 |
| Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval. | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
| Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval. | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
| FG001 | T/R2/R1 | Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
| FG002 | R1/T/R2 | Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
| FG003 | R1/R2/T | Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
| FG004 | R2/T/R1 | Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
| FG005 | R2/R1/T | Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days. |
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| NOT COMPLETED |
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Treated Set: All subjects who received at least 1 dose of investigational treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1). |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values. | Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint. | Posted | Mean | Standard Error | ms | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
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| Secondary | Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment | Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated. QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values. | ECG analysis set (ECGS) | Posted | Mean | Standard Error | ms | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1 |
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| Secondary | Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval. | ECG analysis set (ECGS) | Posted | Mean | Standard Error | bpm | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
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| Secondary | Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy | Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval. | ECG analysis set (ECGS) | Posted | Mean | Standard Error | bpm | 20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1 |
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From the first drug administration until 8 days after the last drug administration, upto 9 days for Moxifloxacin and upto 11 days for BI 207127 + Faldaprevir and Placebo.
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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 | BI 207127 + Faldaprevir | Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water. | 0 | 32 | 17 | 32 | ||
| EG001 | Moxifloxacin | Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water. | 0 | 31 | 4 | 31 | ||
| EG002 | Placebo (BI 207127) + Placebo (Faldaprevir) | Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water. | 0 | 32 | 7 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C000592437 | deleobuvir |
| C552340 | faldaprevir |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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