Trial Outcomes & Findings for Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects. (NCT NCT01965431)
NCT ID: NCT01965431
Last Updated: 2016-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
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
Results posted on
2016-04-14
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other than stated above
|
6
|
5
|
6
|
6
|
6
|
6
|
Baseline Characteristics
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Baseline characteristics by cohort
| Measure |
Overall Study
n=48 Participants
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).
|
|---|---|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
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.
Outcome measures
| Measure |
BI 207127+ Faldaprevir
n=31 Participants
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 day 1 with 240 mL of water.
|
Placebo to BI 207127 + Placebo to Faldaprevir
n=32 Participants
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 day 1 with 240 mL of water.
|
|---|---|---|
|
Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
|
-0.47 ms
Standard Error 1.65
|
-8.37 ms
Standard Error 1.64
|
SECONDARY outcome
Timeframe: 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 1Population: ECG analysis set (ECGS)
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.
Outcome measures
| Measure |
BI 207127+ Faldaprevir
n=31 Participants
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 day 1 with 240 mL of water.
|
Placebo to BI 207127 + Placebo to Faldaprevir
n=32 Participants
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 day 1 with 240 mL of water.
|
|---|---|---|
|
Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment
|
14.95 ms
Standard Error 1.84
|
2.25 ms
Standard Error 1.74
|
SECONDARY outcome
Timeframe: 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 1Population: ECG analysis set (ECGS)
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.
Outcome measures
| Measure |
BI 207127+ Faldaprevir
n=31 Participants
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 day 1 with 240 mL of water.
|
Placebo to BI 207127 + Placebo to Faldaprevir
n=32 Participants
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 day 1 with 240 mL of water.
|
|---|---|---|
|
Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
|
-3.47 bpm
Standard Error 0.88
|
-3.64 bpm
Standard Error 0.88
|
SECONDARY outcome
Timeframe: 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 1Population: ECG analysis set (ECGS)
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.
Outcome measures
| Measure |
BI 207127+ Faldaprevir
n=31 Participants
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 day 1 with 240 mL of water.
|
Placebo to BI 207127 + Placebo to Faldaprevir
n=32 Participants
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 day 1 with 240 mL of water.
|
|---|---|---|
|
Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy
|
-0.68 bpm
Standard Error 0.88
|
3.74 bpm
Standard Error 0.87
|
Adverse Events
BI 207127 + Faldaprevir
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (BI 207127) + Placebo (Faldaprevir)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 207127 + Faldaprevir
n=32 participants at risk
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.
|
Moxifloxacin
n=31 participants at risk
Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
|
Placebo (BI 207127) + Placebo (Faldaprevir)
n=32 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
9.4%
3/32 • 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.
|
0.00%
0/31 • 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.
|
3.1%
1/32 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • 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.
|
0.00%
0/31 • 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.
|
0.00%
0/32 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
5/32 • 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.
|
3.2%
1/31 • 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.
|
3.1%
1/32 • 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.
|
|
Gastrointestinal disorders
Nausea
|
15.6%
5/32 • 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.
|
3.2%
1/31 • 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.
|
0.00%
0/32 • 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.
|
|
General disorders
Fatigue
|
3.1%
1/32 • 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.
|
3.2%
1/31 • 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.
|
6.2%
2/32 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • 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.
|
3.2%
1/31 • 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.
|
9.4%
3/32 • 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.
|
|
Nervous system disorders
Headache
|
31.2%
10/32 • 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.
|
0.00%
0/31 • 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.
|
15.6%
5/32 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
2/32 • 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.
|
0.00%
0/31 • 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.
|
0.00%
0/32 • 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.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place