Trial Outcomes & Findings for Thorough QT/QTc of Pritelivir in Healthy Subjects (NCT NCT05671029)
NCT ID: NCT05671029
Last Updated: 2025-03-14
Results Overview
Mean QTcF values using the Frederica correction method derived from 12-lead ECGs were used to define the effects of pritelivir in comparison with placebo in male and female subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Day -2 to Day 20
Results posted on
2025-03-14
Participant Flow
Participant milestones
| Measure |
Group 1
Subjects (32 male and female subjects) receive 400 mg pritelivir on Day 1, 100 mg pritelivir from Day 2 to 6 and 400 mg pritelivir from Day 7 to 16.
Furthermore, these subjects receive moxifloxacin matching placebo on the Days 2 and 17.
Pritelivir and moxifloxacin placebo: oral administration
|
Group 2a
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2a as verum tablets in Group1.
Furthermore, these subjects receive 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.
Pritelivir placebo, moxifloxacin and moxifloxacin placebo: oral administration
|
Group 2b
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2b as verum tablets in Group1.
Furthermore, these subjects receive moxifloxacin matching placebo on Day 2 and 400 mg moxifloxacin on Day 17.
Pritelivir placebo, moxifloxacin placebo and moxifloxacin: oral administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
16
|
16
|
|
Overall Study
COMPLETED
|
32
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thorough QT/QTc of Pritelivir in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Group 1
n=32 Participants
Subjects (32 male and female subjects) receive 400 mg pritelivir on Day 1, 100 mg pritelivir from Day 2 to 6 and 400 mg pritelivir from Day 7 to 16.
Furthermore, these subjects receive moxifloxacin matching placebo on the Days 2 and 17.
Pritelivir and moxifloxacin placebo: oral administration
|
Group 2a
n=16 Participants
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2a as verum tablets in Group1.
Furthermore, these subjects receive 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.
Pritelivir placebo, moxifloxacin and moxifloxacin placebo: oral administration
|
Group 2b
n=16 Participants
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2b as verum tablets in Group1.
Furthermore, these subjects receive moxifloxacin matching placebo on Day 2 and 400 mg moxifloxacin on Day 17.
Pritelivir placebo, moxifloxacin placebo and moxifloxacin: oral administration
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 4.74 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 4.78 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 6.23 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 5.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day -2 to Day 20Population: Time course of the drug effect on QTcF: Model based estimates (ECG Set).
Mean QTcF values using the Frederica correction method derived from 12-lead ECGs were used to define the effects of pritelivir in comparison with placebo in male and female subjects.
Outcome measures
| Measure |
Group 1
n=32 Participants
Subjects (32 male and female subjects) received 400 mg pritelivir on Day 1, 100 mg pritelivir from Day 2 to 6 and 400 mg pritelivir from Day 7 to 16.
Furthermore, these subjects received moxifloxacin matching placebo on the Days 2 and 17.
Pritelivir and moxifloxacin placebo: oral administration
|
Group 2a
n=16 Participants
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir placebo from Day 1 to Day 16 in Group 2a as verum tablets in Group 1.
Furthermore, these subjects received 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.
Pritelivir placebo, moxifloxacin and moxifloxacin placebo: oral administration
|
Group 2b
n=16 Participants
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir placebo from Day 1 to Day 16 in Group 2b as verum tablets in Group 1.
Furthermore, these subjects received 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.
Pritelivir placebo, moxifloxacin and moxifloxacin placebo: oral administration.
|
|---|---|---|---|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, -1 hour
|
402.66 ms
Standard Deviation 15.198
|
405.23 ms
Standard Deviation 17.208
|
401.94 ms
Standard Deviation 16.989
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, -40 minutes
|
404.55 ms
Standard Deviation 15.043
|
408.19 ms
Standard Deviation 17.040
|
404.21 ms
Standard Deviation 17.782
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, -20 minutes
|
405.66 ms
Standard Deviation 15.781
|
409.10 ms
Standard Deviation 15.934
|
405.19 ms
Standard Deviation 19.805
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 15 minutes
|
405.86 ms
Standard Deviation 15.653
|
407.06 ms
Standard Deviation 14.679
|
406.23 ms
Standard Deviation 16.081
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 30 minutes
|
400.94 ms
Standard Deviation 14.466
|
403.96 ms
Standard Deviation 15.311
|
398.56 ms
Standard Deviation 17.347
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 45 minutes
|
401.82 ms
Standard Deviation 13.891
|
405.48 ms
Standard Deviation 17.832
|
402.13 ms
Standard Deviation 17.295
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 1 hr
|
403.99 ms
Standard Deviation 15.280
|
405.69 ms
Standard Deviation 17.724
|
403.27 ms
Standard Deviation 20.122
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 2 hr
|
403.34 ms
Standard Deviation 13.638
|
406.42 ms
Standard Deviation 16.724
|
404.06 ms
Standard Deviation 19.436
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 3 hr
|
404.70 ms
Standard Deviation 15.006
|
409.08 ms
Standard Deviation 17.105
|
403.60 ms
Standard Deviation 18.037
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 4 hr
|
405.84 ms
Standard Deviation 14.719
|
407.63 ms
Standard Deviation 16.228
|
403.75 ms
Standard Deviation 19,248
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 5 hr
|
398.16 ms
Standard Deviation 13.577
|
401.54 ms
Standard Deviation 16.387
|
401.29 ms
Standard Deviation 15.948
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 6 hr
|
396.48 ms
Standard Deviation 13.705
|
397.56 ms
Standard Deviation 15.982
|
396.98 ms
Standard Deviation 16.573
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 7 hr
|
397.40 ms
Standard Deviation 13.037
|
398.69 ms
Standard Deviation 17,711
|
396.65 ms
Standard Deviation 16.517
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 8 hr
|
398.92 ms
Standard Deviation 14.727
|
401.81 ms
Standard Deviation 16.308
|
397.98 ms
Standard Deviation 17.455
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 1, 12 hr
|
402.41 ms
Standard Deviation 11.990
|
402.63 ms
Standard Deviation 15.583
|
402.96 ms
Standard Deviation 17.687
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, -1 hr
|
406.43 ms
Standard Deviation 14.456
|
404.94 ms
Standard Deviation 13.207
|
404.63 ms
Standard Deviation 20.971
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, -40 minutes
|
405.40 ms
Standard Deviation 16.410
|
407.56 ms
Standard Deviation 16.518
|
406.60 ms
Standard Deviation 18.966
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, -20 minutes
|
407.01 ms
Standard Deviation 16.483
|
405.33 ms
Standard Deviation 14.640
|
407.94 ms
Standard Deviation 16.662
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 1 hr
|
404.76 ms
Standard Deviation 15.722
|
406.04 ms
Standard Deviation 18.259
|
404.23 ms
Standard Deviation 20.257
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 2 hr
|
405.93 ms
Standard Deviation 15.895
|
404.54 ms
Standard Deviation 17.555
|
404.29 ms
Standard Deviation 19,128
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 3 hr
|
405.34 ms
Standard Deviation 17.242
|
404.81 ms
Standard Deviation 18.170
|
405.15 ms
Standard Deviation 18.768
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 4 hr
|
404.73 ms
Standard Deviation 16.959
|
406.44 ms
Standard Deviation 18.839
|
405.63 ms
Standard Deviation 22.097
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 5 hr
|
398.04 ms
Standard Deviation 13.348
|
396.40 ms
Standard Deviation 14.502
|
401.42 ms
Standard Deviation 14.800
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 6 hr
|
395.97 ms
Standard Deviation 14.423
|
396.48 ms
Standard Deviation 15.856
|
397.83 ms
Standard Deviation 18.350
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 7 hr
|
396.82 ms
Standard Deviation 14.461
|
396.10 ms
Standard Deviation 15.270
|
394.21 ms
Standard Deviation 18.831
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 8 hr
|
400.02 ms
Standard Deviation 13.161
|
397.63 ms
Standard Deviation 17.160
|
398.40 ms
Standard Deviation 16.213
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 6, 12 hr
|
399.09 ms
Standard Deviation 12.784
|
396.92 ms
Standard Deviation 16.245
|
399.17 ms
Standard Deviation 17.726
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, -1 hr
|
403.56 ms
Standard Deviation 15.159
|
405.54 ms
Standard Deviation 13.995
|
404.79 ms
Standard Deviation 15.734
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, -40 minutes
|
404.81 ms
Standard Deviation 15.116
|
405.54 ms
Standard Deviation 17.129
|
405.52 ms
Standard Deviation 15.714
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, -20 minutes
|
405.36 ms
Standard Deviation 13.483
|
408.75 ms
Standard Deviation 15.479
|
406.38 ms
Standard Deviation 14.649
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 1 hr
|
403.93 ms
Standard Deviation 14.543
|
404.71 ms
Standard Deviation 15.240
|
404.88 ms
Standard Deviation 15.248
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 2 hr
|
404.14 ms
Standard Deviation 14.856
|
407.85 ms
Standard Deviation 15.755
|
405.15 ms
Standard Deviation 18.643
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 3 hr
|
405.32 ms
Standard Deviation 15.513
|
405.52 ms
Standard Deviation 17.318
|
406.83 ms
Standard Deviation 16.953
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 4 hr
|
405.74 ms
Standard Deviation 15.966
|
406.85 ms
Standard Deviation 17.257
|
405.38 ms
Standard Deviation 16.946
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 5 hr
|
398.14 ms
Standard Deviation 13.121
|
399.71 ms
Standard Deviation 17.031
|
399.56 ms
Standard Deviation 14.704
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 6 hr
|
395.29 ms
Standard Deviation 12.566
|
397.60 ms
Standard Deviation 16.424
|
396.04 ms
Standard Deviation 16.262
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 7 hr
|
396.54 ms
Standard Deviation 13.894
|
395.44 ms
Standard Deviation 15.874
|
396.42 ms
Standard Deviation 17.022
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 8 hr
|
400.52 ms
Standard Deviation 16.196
|
399.52 ms
Standard Deviation 16.536
|
398.46 ms
Standard Deviation 15.975
|
|
Effects of Pritelivir on the QTcF Interval (QTc Using Fridericia Correction Method) in Comparison With Placebo in Male and Female Subjects.
Day 16, 12 hr
|
398.61 ms
Standard Deviation 13.372
|
399.00 ms
Standard Deviation 14.569
|
400.23 ms
Standard Deviation 15.474
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 2a
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2b
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=32 participants at risk
Subjects (32 male and female subjects) receive 400 mg pritelivir on Day 1, 100 mg pritelivir from Day 2 to 6 and 400 mg pritelivir from Day 7 to 16.
Furthermore, these subjects receive moxifloxacin matching placebo on the Days 2 and 17.
Pritelivir and moxifloxacin placebo: oral administration
|
Group 2a
n=16 participants at risk
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2a as verum tablets in Group1.
Furthermore, these subjects receive 400 mg moxifloxacin on Day 2 and moxifloxacin matching placebo on Day 17.
Pritelivir placebo, moxifloxacin and moxifloxacin placebo: oral administration
|
Group 2b
n=16 participants at risk
Subjects (16 male and female subjects) received the respective amounts of tablets of matching pritelivir matching placebo on Day 1 to Day 16 in Group 2b as verum tablets in Group1.
Furthermore, these subjects receive moxifloxacin matching placebo on Day 2 and 400 mg moxifloxacin on Day 17.
Pritelivir placebo, moxifloxacin placebo and moxifloxacin: oral administration
|
|---|---|---|---|
|
Cardiac disorders
dizziness
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Cardiac disorders
dizziness postural
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
18.8%
3/16 • Number of events 3 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
12.5%
2/16 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
12.5%
2/16 • Number of events 3 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Gastrointestinal disorders
Toothache
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.6%
5/32 • Number of events 5 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Injury, poisoning and procedural complications
Neck Injury
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
25.0%
4/16 • Number of events 4 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
12.5%
2/16 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
15.6%
5/32 • Number of events 6 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
25.0%
4/16 • Number of events 4 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
18.8%
3/16 • Number of events 5 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Erythema ab igne
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
2/32 • Number of events 2 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/32 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
6.2%
1/16 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.1%
1/32 • Number of events 1 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
0.00%
0/16 • 39 days
Phase 1 trial primarily compares 2 parallel groups: Group 1 receiving pritelivir verum and Group 2 receiving matching pritelivir placebo and moxifloxacin. In Group 1 the different pritelivir doses were defined as one intervention with no differentiation between doses, to compare versus pritelivir placebo in Group 2 only. Group 2 (pritelivir placebo arm) was subdivided into subgroups 2a and 2b as subjects received 400 mg moxifloxacin on different days, Day 2 and Day 17, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place