Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia (NCT NCT04364269)
NCT ID: NCT04364269
Last Updated: 2023-12-14
Results Overview
Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAE. Please refer to the detailed tables included on the Adverse Event Module for specifics.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
From baseline to Week 16
Results posted on
2023-12-14
Participant Flow
From a total of 35 screened participants, 25 were randomized in the study. A total of 10 participants were not randomised, among which 2 participants withdrew their consent, and 8 participants did not meet the inclusion criteria.
Participant milestones
| Measure |
VIT-2763 QD
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
4
|
|
Overall Study
COMPLETED
|
8
|
11
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
VIT-2763 QD
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia
Baseline characteristics by cohort
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
Greece
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Lebanon
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 16Population: The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.
Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAE. Please refer to the detailed tables included on the Adverse Event Module for specifics.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 12Population: The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.
Summary of the values by visit from baseline and changes from baseline by post-baseline visit.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Baseline
|
114.2 millimeters of mercury (mmHg)
Standard Deviation 11.62
|
114.7 millimeters of mercury (mmHg)
Standard Deviation 13.88
|
114.8 millimeters of mercury (mmHg)
Standard Deviation 12.97
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Week 1
|
115.0 millimeters of mercury (mmHg)
Standard Deviation 8.35
|
116.7 millimeters of mercury (mmHg)
Standard Deviation 10.65
|
104.0 millimeters of mercury (mmHg)
Standard Deviation 8.98
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change from Baseline to Week 1
|
0.8 millimeters of mercury (mmHg)
Standard Deviation 8.94
|
2.0 millimeters of mercury (mmHg)
Standard Deviation 9.72
|
-10.8 millimeters of mercury (mmHg)
Standard Deviation 10.90
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Week 2
|
113.9 millimeters of mercury (mmHg)
Standard Deviation 9.41
|
118.3 millimeters of mercury (mmHg)
Standard Deviation 14.85
|
114.8 millimeters of mercury (mmHg)
Standard Deviation 15.06
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change from Baseline to Week 2
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 6.60
|
3.6 millimeters of mercury (mmHg)
Standard Deviation 8.78
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 2.83
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Week 4
|
112.0 millimeters of mercury (mmHg)
Standard Deviation 11.20
|
113.9 millimeters of mercury (mmHg)
Standard Deviation 12.41
|
104.8 millimeters of mercury (mmHg)
Standard Deviation 6.85
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change from Baseline to Week 4
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 8.77
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 8.51
|
-10.0 millimeters of mercury (mmHg)
Standard Deviation 14.72
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Week 8
|
114.9 millimeters of mercury (mmHg)
Standard Deviation 7.41
|
113.8 millimeters of mercury (mmHg)
Standard Deviation 10.54
|
109.8 millimeters of mercury (mmHg)
Standard Deviation 12.61
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change from Baseline to Week 8
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 11.11
|
0.9 millimeters of mercury (mmHg)
Standard Deviation 9.63
|
-5.0 millimeters of mercury (mmHg)
Standard Deviation 1.63
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Week 12
|
113.4 millimeters of mercury (mmHg)
Standard Deviation 11.02
|
112.8 millimeters of mercury (mmHg)
Standard Deviation 11.31
|
107.5 millimeters of mercury (mmHg)
Standard Deviation 10.08
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP Change from Baseline to Week 12
|
-0.8 millimeters of mercury (mmHg)
Standard Deviation 13.02
|
-0.1 millimeters of mercury (mmHg)
Standard Deviation 10.85
|
-7.3 millimeters of mercury (mmHg)
Standard Deviation 3.40
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Baseline
|
65.94 millimeters of mercury (mmHg)
Standard Deviation 10.088
|
65.00 millimeters of mercury (mmHg)
Standard Deviation 10.189
|
66.50 millimeters of mercury (mmHg)
Standard Deviation 7.853
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Week 1
|
66.44 millimeters of mercury (mmHg)
Standard Deviation 6.710
|
69.33 millimeters of mercury (mmHg)
Standard Deviation 9.921
|
61.75 millimeters of mercury (mmHg)
Standard Deviation 4.856
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change from Baseline to Week 1
|
0.50 millimeters of mercury (mmHg)
Standard Deviation 4.886
|
4.33 millimeters of mercury (mmHg)
Standard Deviation 6.344
|
-4.75 millimeters of mercury (mmHg)
Standard Deviation 6.185
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Week 2
|
65.89 millimeters of mercury (mmHg)
Standard Deviation 9.545
|
68.83 millimeters of mercury (mmHg)
Standard Deviation 11.535
|
64.00 millimeters of mercury (mmHg)
Standard Deviation 6.055
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change from Baseline to Week 2
|
-0.06 millimeters of mercury (mmHg)
Standard Deviation 5.353
|
3.83 millimeters of mercury (mmHg)
Standard Deviation 8.726
|
-2.50 millimeters of mercury (mmHg)
Standard Deviation 3.000
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Week 4
|
65.22 millimeters of mercury (mmHg)
Standard Deviation 11.043
|
62.33 millimeters of mercury (mmHg)
Standard Deviation 9.069
|
62.75 millimeters of mercury (mmHg)
Standard Deviation 3.775
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change from Baseline to Week 4
|
-0.72 millimeters of mercury (mmHg)
Standard Deviation 9.398
|
-2.67 millimeters of mercury (mmHg)
Standard Deviation 9.921
|
-3.75 millimeters of mercury (mmHg)
Standard Deviation 5.058
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Week 8
|
63.44 millimeters of mercury (mmHg)
Standard Deviation 6.579
|
67.18 millimeters of mercury (mmHg)
Standard Deviation 9.174
|
66.75 millimeters of mercury (mmHg)
Standard Deviation 7.500
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change from Baseline to Week 8
|
-2.50 millimeters of mercury (mmHg)
Standard Deviation 8.216
|
3.27 millimeters of mercury (mmHg)
Standard Deviation 8.439
|
0.25 millimeters of mercury (mmHg)
Standard Deviation 7.848
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Week 12
|
63.67 millimeters of mercury (mmHg)
Standard Deviation 7.697
|
67.64 millimeters of mercury (mmHg)
Standard Deviation 9.657
|
62.50 millimeters of mercury (mmHg)
Standard Deviation 3.317
|
|
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP Change from Baseline to Week 12
|
-2.28 millimeters of mercury (mmHg)
Standard Deviation 10.140
|
3.73 millimeters of mercury (mmHg)
Standard Deviation 6.310
|
-4.00 millimeters of mercury (mmHg)
Standard Deviation 6.880
|
PRIMARY outcome
Timeframe: From baseline to Week 12Population: The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.
Summary of the values by visit from baseline and changes from baseline by post-baseline visit.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Changes in the Heart Rate
Baseline
|
82.00 Pulse Rate (bpm)
Standard Deviation 12.135
|
77.71 Pulse Rate (bpm)
Standard Deviation 10.208
|
73.75 Pulse Rate (bpm)
Standard Deviation 5.560
|
|
Changes in the Heart Rate
Week 1
|
82.33 Pulse Rate (bpm)
Standard Deviation 11.694
|
80.33 Pulse Rate (bpm)
Standard Deviation 9.875
|
70.75 Pulse Rate (bpm)
Standard Deviation 6.449
|
|
Changes in the Heart Rate
Change from Baseline to Week 1
|
0.33 Pulse Rate (bpm)
Standard Deviation 6.042
|
2.63 Pulse Rate (bpm)
Standard Deviation 5.859
|
-3.00 Pulse Rate (bpm)
Standard Deviation 5.715
|
|
Changes in the Heart Rate
Week 2
|
83.56 Pulse Rate (bpm)
Standard Deviation 12.856
|
75.83 Pulse Rate (bpm)
Standard Deviation 9.953
|
75.00 Pulse Rate (bpm)
Standard Deviation 8.756
|
|
Changes in the Heart Rate
Change from Baseline to Week 2
|
1.56 Pulse Rate (bpm)
Standard Deviation 10.442
|
-1.88 Pulse Rate (bpm)
Standard Deviation 8.263
|
1.25 Pulse Rate (bpm)
Standard Deviation 3.775
|
|
Changes in the Heart Rate
Week 4
|
82.33 Pulse Rate (bpm)
Standard Deviation 14.414
|
77.92 Pulse Rate (bpm)
Standard Deviation 9.830
|
73.25 Pulse Rate (bpm)
Standard Deviation 3.775
|
|
Changes in the Heart Rate
Change from Baseline to Week 4
|
0.33 Pulse Rate (bpm)
Standard Deviation 8.818
|
0.21 Pulse Rate (bpm)
Standard Deviation 5.541
|
-0.50 Pulse Rate (bpm)
Standard Deviation 1.915
|
|
Changes in the Heart Rate
Week 8
|
83.22 Pulse Rate (bpm)
Standard Deviation 11.322
|
80.27 Pulse Rate (bpm)
Standard Deviation 10.992
|
72.50 Pulse Rate (bpm)
Standard Deviation 5.196
|
|
Changes in the Heart Rate
Change from Baseline to Week 8
|
1.22 Pulse Rate (bpm)
Standard Deviation 6.648
|
2.68 Pulse Rate (bpm)
Standard Deviation 9.040
|
-1.25 Pulse Rate (bpm)
Standard Deviation 7.411
|
|
Changes in the Heart Rate
Week 12
|
81.44 Pulse Rate (bpm)
Standard Deviation 9.002
|
79.91 Pulse Rate (bpm)
Standard Deviation 8.734
|
74.25 Pulse Rate (bpm)
Standard Deviation 4.193
|
|
Changes in the Heart Rate
Change from Baseline to Week 12
|
-0.56 Pulse Rate (bpm)
Standard Deviation 8.719
|
2.32 Pulse Rate (bpm)
Standard Deviation 9.419
|
0.50 Pulse Rate (bpm)
Standard Deviation 6.137
|
PRIMARY outcome
Timeframe: From baseline to Week 12Population: The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization
Values by visit from baseline and changes from baseline by post-baseline visit. The following ECG parameters were recorded: PR interval, QRS duration, QT interval, RR interval and QTcF interval. PR interval represents the time from the onset of the P wave to the start of the QRS complex. QRS duration represents the time required for a stimulus to spread through the ventricles (ventricular depolarization). QT interval represents the time from the start of the Q wave to the end of the T wave. RR interval represents the time from the onset of one R wave to the onset of the next one, one complete cardiac cycle. QT corrected for heart rate (QTc) interval reflects ventricular repolarization.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Baseline
|
158.3 milliseconds (ms)
Standard Deviation 25.14
|
147.6 milliseconds (ms)
Standard Deviation 20.05
|
175.8 milliseconds (ms)
Standard Deviation 38.92
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Baseline 2h post-dose
|
161.2 milliseconds (ms)
Standard Deviation 21.28
|
155.1 milliseconds (ms)
Standard Deviation 17.98
|
175.0 milliseconds (ms)
Standard Deviation 14.07
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Baseline 2h post-dose
|
2.9 milliseconds (ms)
Standard Deviation 25.78
|
6.3 milliseconds (ms)
Standard Deviation 16.45
|
-0.8 milliseconds (ms)
Standard Deviation 38.59
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Week 1
|
159.2 milliseconds (ms)
Standard Deviation 22.90
|
153.0 milliseconds (ms)
Standard Deviation 14.12
|
189.5 milliseconds (ms)
Standard Deviation 18.72
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Week 1
|
0.9 milliseconds (ms)
Standard Deviation 16.59
|
4.7 milliseconds (ms)
Standard Deviation 12.71
|
13.8 milliseconds (ms)
Standard Deviation 25.67
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Week 2
|
167.6 milliseconds (ms)
Standard Deviation 26.49
|
153.0 milliseconds (ms)
Standard Deviation 17.87
|
185.5 milliseconds (ms)
Standard Deviation 4.43
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Week 2
|
9.2 milliseconds (ms)
Standard Deviation 27.64
|
5.5 milliseconds (ms)
Standard Deviation 13.56
|
9.8 milliseconds (ms)
Standard Deviation 37.56
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Week 4
|
154.0 milliseconds (ms)
Standard Deviation 26.49
|
154.2 milliseconds (ms)
Standard Deviation 21.19
|
185.0 milliseconds (ms)
Standard Deviation 7.39
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Week 4
|
-4.3 milliseconds (ms)
Standard Deviation 18.85
|
8.1 milliseconds (ms)
Standard Deviation 15.48
|
9.3 milliseconds (ms)
Standard Deviation 33.42
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Week 8
|
161.2 milliseconds (ms)
Standard Deviation 19.34
|
153.5 milliseconds (ms)
Standard Deviation 20.61
|
185.8 milliseconds (ms)
Standard Deviation 10.14
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Week 8
|
2.9 milliseconds (ms)
Standard Deviation 17.05
|
7.1 milliseconds (ms)
Standard Deviation 12.66
|
10.0 milliseconds (ms)
Standard Deviation 32.86
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Week 12
|
160.6 milliseconds (ms)
Standard Deviation 19.55
|
156.6 milliseconds (ms)
Standard Deviation 14.47
|
182.8 milliseconds (ms)
Standard Deviation 11.98
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
PR interval - Change from Baseline to Week 12
|
2.2 milliseconds (ms)
Standard Deviation 19.50
|
11.5 milliseconds (ms)
Standard Deviation 14.25
|
7.0 milliseconds (ms)
Standard Deviation 36.09
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Baseline
|
94.0 milliseconds (ms)
Standard Deviation 18.73
|
88.8 milliseconds (ms)
Standard Deviation 19.17
|
119.3 milliseconds (ms)
Standard Deviation 50.12
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Baseline 2h post-dose
|
94.3 milliseconds (ms)
Standard Deviation 20.21
|
95.8 milliseconds (ms)
Standard Deviation 10.96
|
85.0 milliseconds (ms)
Standard Deviation 11.60
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Baseline 2h post-dose
|
0.3 milliseconds (ms)
Standard Deviation 4.82
|
7.0 milliseconds (ms)
Standard Deviation 14.39
|
-34.3 milliseconds (ms)
Standard Deviation 55.27
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Week 1
|
98.4 milliseconds (ms)
Standard Deviation 23.16
|
96.1 milliseconds (ms)
Standard Deviation 11.27
|
98.0 milliseconds (ms)
Standard Deviation 16.57
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Week 1
|
4.4 milliseconds (ms)
Standard Deviation 14.75
|
7.3 milliseconds (ms)
Standard Deviation 13.45
|
-21.3 milliseconds (ms)
Standard Deviation 65.76
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Week 2
|
94.0 milliseconds (ms)
Standard Deviation 29.01
|
96.3 milliseconds (ms)
Standard Deviation 14.13
|
91.3 milliseconds (ms)
Standard Deviation 12.09
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Week 2
|
0.0 milliseconds (ms)
Standard Deviation 23.04
|
7.6 milliseconds (ms)
Standard Deviation 17.96
|
-28.0 milliseconds (ms)
Standard Deviation 61.36
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Week 4
|
92.3 milliseconds (ms)
Standard Deviation 23.32
|
92.6 milliseconds (ms)
Standard Deviation 15.11
|
94.3 milliseconds (ms)
Standard Deviation 8.10
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Week 4
|
-1.7 milliseconds (ms)
Standard Deviation 11.16
|
6.0 milliseconds (ms)
Standard Deviation 16.76
|
-25.0 milliseconds (ms)
Standard Deviation 54.02
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Week 8
|
91.0 milliseconds (ms)
Standard Deviation 24.72
|
94.9 milliseconds (ms)
Standard Deviation 18.27
|
93.3 milliseconds (ms)
Standard Deviation 10.81
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Week 8
|
-3.0 milliseconds (ms)
Standard Deviation 15.99
|
7.4 milliseconds (ms)
Standard Deviation 28.52
|
-26.0 milliseconds (ms)
Standard Deviation 60.02
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Week 12
|
94.3 milliseconds (ms)
Standard Deviation 27.31
|
84.8 milliseconds (ms)
Standard Deviation 18.66
|
91.8 milliseconds (ms)
Standard Deviation 10.59
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QRS duration - Change from Baseline to Week 12
|
0.3 milliseconds (ms)
Standard Deviation 20.64
|
-2.7 milliseconds (ms)
Standard Deviation 23.70
|
-27.5 milliseconds (ms)
Standard Deviation 60.69
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Baseline
|
371.7 milliseconds (ms)
Standard Deviation 76.41
|
374.2 milliseconds (ms)
Standard Deviation 21.78
|
420.8 milliseconds (ms)
Standard Deviation 48.75
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Baseline 2h post-dose
|
385.7 milliseconds (ms)
Standard Deviation 50.89
|
376.8 milliseconds (ms)
Standard Deviation 22.25
|
379.5 milliseconds (ms)
Standard Deviation 30.17
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Baseline 2h post-dose
|
14.0 milliseconds (ms)
Standard Deviation 61.00
|
2.6 milliseconds (ms)
Standard Deviation 21.49
|
-41.3 milliseconds (ms)
Standard Deviation 68.30
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Week 1
|
394.1 milliseconds (ms)
Standard Deviation 47.36
|
374.8 milliseconds (ms)
Standard Deviation 33.12
|
381.5 milliseconds (ms)
Standard Deviation 32.18
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Week 1
|
22.4 milliseconds (ms)
Standard Deviation 57.20
|
0.7 milliseconds (ms)
Standard Deviation 28.96
|
-39.3 milliseconds (ms)
Standard Deviation 71.63
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Week 2
|
384.0 milliseconds (ms)
Standard Deviation 55.52
|
367.0 milliseconds (ms)
Standard Deviation 24.68
|
378.3 milliseconds (ms)
Standard Deviation 27.89
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Week 2
|
12.3 milliseconds (ms)
Standard Deviation 76.14
|
-7.2 milliseconds (ms)
Standard Deviation 27.61
|
-42.5 milliseconds (ms)
Standard Deviation 61.87
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Week 4
|
370.1 milliseconds (ms)
Standard Deviation 67.13
|
373.6 milliseconds (ms)
Standard Deviation 21.22
|
378.0 milliseconds (ms)
Standard Deviation 36.51
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Week 4
|
-1.6 milliseconds (ms)
Standard Deviation 23.07
|
0.9 milliseconds (ms)
Standard Deviation 24.94
|
-42.8 milliseconds (ms)
Standard Deviation 61.50
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Week 8
|
389.7 milliseconds (ms)
Standard Deviation 39.20
|
379.4 milliseconds (ms)
Standard Deviation 25.08
|
381.8 milliseconds (ms)
Standard Deviation 37.99
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Week 8
|
18.0 milliseconds (ms)
Standard Deviation 69.60
|
4.6 milliseconds (ms)
Standard Deviation 22.59
|
-39.0 milliseconds (ms)
Standard Deviation 64.59
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Week 12
|
380.9 milliseconds (ms)
Standard Deviation 59.97
|
364.2 milliseconds (ms)
Standard Deviation 36.22
|
388.3 milliseconds (ms)
Standard Deviation 42.85
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QT interval - Change from Baseline to Week 12
|
9.2 milliseconds (ms)
Standard Deviation 33.53
|
-10.5 milliseconds (ms)
Standard Deviation 33.69
|
-32.5 milliseconds (ms)
Standard Deviation 72.06
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Baseline
|
789.4 milliseconds (ms)
Standard Deviation 128.89
|
801.4 milliseconds (ms)
Standard Deviation 95.56
|
877.5 milliseconds (ms)
Standard Deviation 114.65
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Baseline 2h post-dose
|
781.2 milliseconds (ms)
Standard Deviation 155.21
|
805.5 milliseconds (ms)
Standard Deviation 119.36
|
812.5 milliseconds (ms)
Standard Deviation 124.38
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Baseline 2h post-dose
|
-8.2 milliseconds (ms)
Standard Deviation 87.78
|
4.1 milliseconds (ms)
Standard Deviation 112.91
|
-65.0 milliseconds (ms)
Standard Deviation 196.09
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Week 1
|
793.2 milliseconds (ms)
Standard Deviation 105.35
|
864.9 milliseconds (ms)
Standard Deviation 149.33
|
826.5 milliseconds (ms)
Standard Deviation 96.57
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Week 1
|
3.8 milliseconds (ms)
Standard Deviation 82.82
|
63.5 milliseconds (ms)
Standard Deviation 137.59
|
-51.0 milliseconds (ms)
Standard Deviation 98.80
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Week 2
|
757.3 milliseconds (ms)
Standard Deviation 120.25
|
830.1 milliseconds (ms)
Standard Deviation 138.34
|
833.8 milliseconds (ms)
Standard Deviation 16.01
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Week 2
|
-32.1 milliseconds (ms)
Standard Deviation 146.70
|
28.7 milliseconds (ms)
Standard Deviation 117.34
|
-43.8 milliseconds (ms)
Standard Deviation 103.92
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Week 4
|
783.7 milliseconds (ms)
Standard Deviation 110.55
|
829.8 milliseconds (ms)
Standard Deviation 154.72
|
825.8 milliseconds (ms)
Standard Deviation 96.08
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Week 4
|
-5.8 milliseconds (ms)
Standard Deviation 62.11
|
34.1 milliseconds (ms)
Standard Deviation 137.64
|
-51.8 milliseconds (ms)
Standard Deviation 111.05
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Week 8
|
765.0 milliseconds (ms)
Standard Deviation 91.52
|
810.1 milliseconds (ms)
Standard Deviation 138.16
|
844.8 milliseconds (ms)
Standard Deviation 135.47
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Week 8
|
-24.4 milliseconds (ms)
Standard Deviation 116.42
|
17.2 milliseconds (ms)
Standard Deviation 108.39
|
-32.8 milliseconds (ms)
Standard Deviation 152.45
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Week 12
|
780.7 milliseconds (ms)
Standard Deviation 140.88
|
812.9 milliseconds (ms)
Standard Deviation 93.89
|
878.3 milliseconds (ms)
Standard Deviation 133.70
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
RR interval - Change from Baseline to Week 12
|
-8.8 milliseconds (ms)
Standard Deviation 115.95
|
20.0 milliseconds (ms)
Standard Deviation 73.46
|
0.8 milliseconds (ms)
Standard Deviation 172.81
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Baseline
|
403.3 milliseconds (ms)
Standard Deviation 80.48
|
400.5 milliseconds (ms)
Standard Deviation 22.76
|
416.8 milliseconds (ms)
Standard Deviation 17.46
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Baseline 2h post-dose
|
419.3 milliseconds (ms)
Standard Deviation 36.58
|
410.1 milliseconds (ms)
Standard Deviation 25.34
|
407.3 milliseconds (ms)
Standard Deviation 13.05
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Baseline 2h post-dose
|
16.0 milliseconds (ms)
Standard Deviation 66.51
|
9.6 milliseconds (ms)
Standard Deviation 22.60
|
-9.5 milliseconds (ms)
Standard Deviation 6.76
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Week 1
|
425.7 milliseconds (ms)
Standard Deviation 37.25
|
397.3 milliseconds (ms)
Standard Deviation 30.44
|
406.8 milliseconds (ms)
Standard Deviation 26.02
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Week 1
|
22.3 milliseconds (ms)
Standard Deviation 65.53
|
-3.3 milliseconds (ms)
Standard Deviation 24.92
|
-10.0 milliseconds (ms)
Standard Deviation 20.38
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Week 2
|
420.8 milliseconds (ms)
Standard Deviation 42.28
|
393.3 milliseconds (ms)
Standard Deviation 28.90
|
402.0 milliseconds (ms)
Standard Deviation 30.30
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Week 2
|
17.4 milliseconds (ms)
Standard Deviation 77.84
|
-7.2 milliseconds (ms)
Standard Deviation 27.52
|
-14.8 milliseconds (ms)
Standard Deviation 14.52
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Week 4
|
401.3 milliseconds (ms)
Standard Deviation 64.21
|
401.8 milliseconds (ms)
Standard Deviation 27.41
|
402.8 milliseconds (ms)
Standard Deviation 23.63
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Week 4
|
-2.0 milliseconds (ms)
Standard Deviation 24.74
|
2.1 milliseconds (ms)
Standard Deviation 24.41
|
-14.0 milliseconds (ms)
Standard Deviation 7.07
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Week 8
|
426.0 milliseconds (ms)
Standard Deviation 30.12
|
399.6 milliseconds (ms)
Standard Deviation 27.17
|
404.3 milliseconds (ms)
Standard Deviation 19.86
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Week 8
|
22.7 milliseconds (ms)
Standard Deviation 80.36
|
0.3 milliseconds (ms)
Standard Deviation 26.86
|
-12.5 milliseconds (ms)
Standard Deviation 4.51
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Week 12
|
414.1 milliseconds (ms)
Standard Deviation 53.40
|
391.4 milliseconds (ms)
Standard Deviation 42.91
|
405.3 milliseconds (ms)
Standard Deviation 25.71
|
|
Changes in 12-lead Electrocardiogram (ECG) Parameters
QTcF interval - Change from Baseline to Week 12
|
10.8 milliseconds (ms)
Standard Deviation 37.94
|
-8.0 milliseconds (ms)
Standard Deviation 37.96
|
-11.5 milliseconds (ms)
Standard Deviation 10.63
|
SECONDARY outcome
Timeframe: From baseline to Week 12Population: The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.
Assessment of total serum Iron from baseline over a 12-week period (absolute and change from baseline). For the serum iron parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Total Serum Iron
Baseline
|
23.81 Micromoles per Litre (umol/L)
Standard Deviation 13.438
|
28.42 Micromoles per Litre (umol/L)
Standard Deviation 9.796
|
30.88 Micromoles per Litre (umol/L)
Standard Deviation 13.329
|
|
Change From Baseline in Total Serum Iron
Week 1
|
12.54 Micromoles per Litre (umol/L)
Standard Deviation 9.159
|
11.38 Micromoles per Litre (umol/L)
Standard Deviation 7.693
|
28.20 Micromoles per Litre (umol/L)
Standard Deviation 17.919
|
|
Change From Baseline in Total Serum Iron
Change from Baselines to Week 1
|
-11.27 Micromoles per Litre (umol/L)
Standard Deviation 7.158
|
-17.03 Micromoles per Litre (umol/L)
Standard Deviation 9.611
|
-2.68 Micromoles per Litre (umol/L)
Standard Deviation 12.365
|
|
Change From Baseline in Total Serum Iron
Week 2
|
11.71 Micromoles per Litre (umol/L)
Standard Deviation 8.622
|
12.99 Micromoles per Litre (umol/L)
Standard Deviation 8.978
|
32.48 Micromoles per Litre (umol/L)
Standard Deviation 15.541
|
|
Change From Baseline in Total Serum Iron
Change from Baseline to Week 2
|
-9.74 Micromoles per Litre (umol/L)
Standard Deviation 4.707
|
-15.43 Micromoles per Litre (umol/L)
Standard Deviation 12.784
|
1.60 Micromoles per Litre (umol/L)
Standard Deviation 3.996
|
|
Change From Baseline in Total Serum Iron
Week 4
|
13.90 Micromoles per Litre (umol/L)
Standard Deviation 12.222
|
12.85 Micromoles per Litre (umol/L)
Standard Deviation 7.583
|
31.08 Micromoles per Litre (umol/L)
Standard Deviation 13.721
|
|
Change From Baseline in Total Serum Iron
Change from Baseline to Week 4
|
-9.33 Micromoles per Litre (umol/L)
Standard Deviation 4.659
|
-14.03 Micromoles per Litre (umol/L)
Standard Deviation 8.432
|
0.20 Micromoles per Litre (umol/L)
Standard Deviation 2.902
|
|
Change From Baseline in Total Serum Iron
Week 8
|
11.35 Micromoles per Litre (umol/L)
Standard Deviation 7.822
|
11.55 Micromoles per Litre (umol/L)
Standard Deviation 9.651
|
26.70 Micromoles per Litre (umol/L)
Standard Deviation 12.040
|
|
Change From Baseline in Total Serum Iron
Change from Baseline to Week 8
|
-11.88 Micromoles per Litre (umol/L)
Standard Deviation 9.627
|
-17.05 Micromoles per Litre (umol/L)
Standard Deviation 11.936
|
-0.37 Micromoles per Litre (umol/L)
Standard Deviation 3.550
|
|
Change From Baseline in Total Serum Iron
Week 12
|
13.72 Micromoles per Litre (umol/L)
Standard Deviation 11.031
|
11.62 Micromoles per Litre (umol/L)
Standard Deviation 6.442
|
27.10 Micromoles per Litre (umol/L)
Standard Deviation 12.856
|
|
Change From Baseline in Total Serum Iron
Change from Baseline to Week 12
|
-10.54 Micromoles per Litre (umol/L)
Standard Deviation 6.782
|
-16.22 Micromoles per Litre (umol/L)
Standard Deviation 10.892
|
0.03 Micromoles per Litre (umol/L)
Standard Deviation 2.701
|
SECONDARY outcome
Timeframe: From baseline to Week 12Population: The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.
Assessment of serum ferritin from baseline over a 12-week period (absolute and change from baseline). For the serum ferritin parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Serum Ferritin
Change from Baseline to Week 4
|
1.05 Microgrammes per Litre (ug/L)
Standard Deviation 61.638
|
89.98 Microgrammes per Litre (ug/L)
Standard Deviation 249.397
|
-50.20 Microgrammes per Litre (ug/L)
Standard Deviation 80.958
|
|
Change From Baseline in Serum Ferritin
Week 8
|
463.67 Microgrammes per Litre (ug/L)
Standard Deviation 206.646
|
508.56 Microgrammes per Litre (ug/L)
Standard Deviation 211.366
|
340.23 Microgrammes per Litre (ug/L)
Standard Deviation 165.356
|
|
Change From Baseline in Serum Ferritin
Change from Baseline to Week 8
|
-11.88 Microgrammes per Litre (ug/L)
Standard Deviation 43.063
|
52.84 Microgrammes per Litre (ug/L)
Standard Deviation 157.952
|
-9.45 Microgrammes per Litre (ug/L)
Standard Deviation 20.577
|
|
Change From Baseline in Serum Ferritin
Baseline
|
403.14 Microgrammes per Litre (ug/L)
Standard Deviation 226.315
|
1133.23 Microgrammes per Litre (ug/L)
Standard Deviation 2119.115
|
440.03 Microgrammes per Litre (ug/L)
Standard Deviation 321.453
|
|
Change From Baseline in Serum Ferritin
Week 1
|
416.76 Microgrammes per Litre (ug/L)
Standard Deviation 220.567
|
471.53 Microgrammes per Litre (ug/L)
Standard Deviation 209.800
|
445.80 Microgrammes per Litre (ug/L)
Standard Deviation 228.244
|
|
Change From Baseline in Serum Ferritin
Change from Baseline to Week 1
|
-10.14 Microgrammes per Litre (ug/L)
Standard Deviation 31.509
|
40.89 Microgrammes per Litre (ug/L)
Standard Deviation 164.466
|
5.77 Microgrammes per Litre (ug/L)
Standard Deviation 93.946
|
|
Change From Baseline in Serum Ferritin
Week 2
|
441.34 Microgrammes per Litre (ug/L)
Standard Deviation 269.599
|
500.79 Microgrammes per Litre (ug/L)
Standard Deviation 230.076
|
411.35 Microgrammes per Litre (ug/L)
Standard Deviation 207.477
|
|
Change From Baseline in Serum Ferritin
Change from Baseline to Week 2
|
3.29 Microgrammes per Litre (ug/L)
Standard Deviation 60.579
|
23.80 Microgrammes per Litre (ug/L)
Standard Deviation 149.147
|
-49.80 Microgrammes per Litre (ug/L)
Standard Deviation 76.867
|
|
Change From Baseline in Serum Ferritin
Week 4
|
476.60 Microgrammes per Litre (ug/L)
Standard Deviation 282.457
|
585.71 Microgrammes per Litre (ug/L)
Standard Deviation 311.224
|
389.83 Microgrammes per Litre (ug/L)
Standard Deviation 240.553
|
|
Change From Baseline in Serum Ferritin
Week 12
|
465.72 Microgrammes per Litre (ug/L)
Standard Deviation 227.378
|
927.42 Microgrammes per Litre (ug/L)
Standard Deviation 1478.471
|
261.70 Microgrammes per Litre (ug/L)
Standard Deviation 53.033
|
|
Change From Baseline in Serum Ferritin
Change from Baseline to Week 12
|
-15.84 Microgrammes per Litre (ug/L)
Standard Deviation 66.208
|
-139.23 Microgrammes per Litre (ug/L)
Standard Deviation 626.380
|
7.25 Microgrammes per Litre (ug/L)
Standard Deviation 57.205
|
SECONDARY outcome
Timeframe: From baseline to Week 12Population: The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.
Assessment of serum transferrin from baseline over a 12-week period (absolute and change from baseline). For the serum transferrin parameter, the "Baseline 2h post-dose" was defined as the value at Visit 3 2h post-dose.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Serum Transferrin
Baseline 2h post-dose
|
1.601 Grammes per Litre (g/L)
Standard Deviation 0.4377
|
1.673 Grammes per Litre (g/L)
Standard Deviation 0.3177
|
1.655 Grammes per Litre (g/L)
Standard Deviation 0.3003
|
|
Change From Baseline in Serum Transferrin
Week 1
|
1.610 Grammes per Litre (g/L)
Standard Deviation 0.4557
|
1.822 Grammes per Litre (g/L)
Standard Deviation 0.3903
|
1.683 Grammes per Litre (g/L)
Standard Deviation 0.2210
|
|
Change From Baseline in Serum Transferrin
Change from Baseline to Week 1
|
0.009 Grammes per Litre (g/L)
Standard Deviation 0.1184
|
0.149 Grammes per Litre (g/L)
Standard Deviation 0.1334
|
0.028 Grammes per Litre (g/L)
Standard Deviation 0.2419
|
|
Change From Baseline in Serum Transferrin
Week 2
|
1.601 Grammes per Litre (g/L)
Standard Deviation 0.5043
|
1.759 Grammes per Litre (g/L)
Standard Deviation 0.3569
|
1.655 Grammes per Litre (g/L)
Standard Deviation 0.2408
|
|
Change From Baseline in Serum Transferrin
Change from Baseline to Week 2
|
-0.014 Grammes per Litre (g/L)
Standard Deviation 0.1516
|
0.087 Grammes per Litre (g/L)
Standard Deviation 0.1429
|
0.000 Grammes per Litre (g/L)
Standard Deviation 0.1846
|
|
Change From Baseline in Serum Transferrin
Week 4
|
1.708 Grammes per Litre (g/L)
Standard Deviation 0.2672
|
1.705 Grammes per Litre (g/L)
Standard Deviation 0.3496
|
1.745 Grammes per Litre (g/L)
Standard Deviation 0.3756
|
|
Change From Baseline in Serum Transferrin
Change from Baseline to Week 4
|
0.053 Grammes per Litre (g/L)
Standard Deviation 0.2014
|
0.054 Grammes per Litre (g/L)
Standard Deviation 0.1535
|
0.090 Grammes per Litre (g/L)
Standard Deviation 0.2740
|
|
Change From Baseline in Serum Transferrin
Week 8
|
1.640 Grammes per Litre (g/L)
Standard Deviation 0.2745
|
1.725 Grammes per Litre (g/L)
Standard Deviation 0.3194
|
1.553 Grammes per Litre (g/L)
Standard Deviation 0.2836
|
|
Change From Baseline in Serum Transferrin
Change from Baseline to Week 8
|
-0.015 Grammes per Litre (g/L)
Standard Deviation 0.0675
|
0.093 Grammes per Litre (g/L)
Standard Deviation 0.1618
|
-0.120 Grammes per Litre (g/L)
Standard Deviation 0.0854
|
|
Change From Baseline in Serum Transferrin
Week 12
|
1.706 Grammes per Litre (g/L)
Standard Deviation 0.1954
|
1.656 Grammes per Litre (g/L)
Standard Deviation 0.2974
|
1.610 Grammes per Litre (g/L)
Standard Deviation 0.4784
|
|
Change From Baseline in Serum Transferrin
Change from Baseline to Week 12
|
-0.040 Grammes per Litre (g/L)
Standard Deviation 0.1116
|
0.100 Grammes per Litre (g/L)
Standard Deviation 0.1044
|
-0.063 Grammes per Litre (g/L)
Standard Deviation 0.1266
|
SECONDARY outcome
Timeframe: From baseline to Week 12Population: The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.
Assessment of TSAT from baseline over a 12-week period (absolute and change from baseline). For the calculated transferrin saturation parameter, the 'Baseline' was collected during the screening period within the biochemistry sample. Transferrin Saturation (TSAT) was calculated as Total Iron /Total Iron Binding Capacity (TIBC) X 100.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 Participants
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Baseline
|
69.3 TSAT Percentage (%)
Standard Deviation 31.16
|
79.0 TSAT Percentage (%)
Standard Deviation 24.05
|
83.3 TSAT Percentage (%)
Standard Deviation 33.50
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Week 1
|
36.8 TSAT Percentage (%)
Standard Deviation 24.44
|
32.2 TSAT Percentage (%)
Standard Deviation 21.44
|
56.5 TSAT Percentage (%)
Standard Deviation 30.56
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Change from Baselone to Week 1
|
-32.6 TSAT Percentage (%)
Standard Deviation 19.55
|
-46.8 TSAT Percentage (%)
Standard Deviation 22.55
|
-26.8 TSAT Percentage (%)
Standard Deviation 28.77
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Week 2
|
36.0 TSAT Percentage (%)
Standard Deviation 22.81
|
35.8 TSAT Percentage (%)
Standard Deviation 24.13
|
71.5 TSAT Percentage (%)
Standard Deviation 33.91
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Change from Baseline to Week 2
|
-29.5 TSAT Percentage (%)
Standard Deviation 14.57
|
-43.2 TSAT Percentage (%)
Standard Deviation 33.23
|
-11.8 TSAT Percentage (%)
Standard Deviation 23.50
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Week 4
|
41.0 TSAT Percentage (%)
Standard Deviation 32.27
|
38.4 TSAT Percentage (%)
Standard Deviation 24.85
|
82.5 TSAT Percentage (%)
Standard Deviation 35.00
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Change from Baseline to Week 4
|
-24.0 TSAT Percentage (%)
Standard Deviation 18.21
|
-38.7 TSAT Percentage (%)
Standard Deviation 27.57
|
-0.8 TSAT Percentage (%)
Standard Deviation 1.50
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Week 8
|
32.3 TSAT Percentage (%)
Standard Deviation 17.48
|
33.5 TSAT Percentage (%)
Standard Deviation 27.08
|
77.3 TSAT Percentage (%)
Standard Deviation 39.26
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Change from Baseline to Week 8
|
-32.7 TSAT Percentage (%)
Standard Deviation 25.80
|
-47.9 TSAT Percentage (%)
Standard Deviation 29.70
|
-0.3 TSAT Percentage (%)
Standard Deviation 0.58
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Week 12
|
36.0 TSAT Percentage (%)
Standard Deviation 25.93
|
34.8 TSAT Percentage (%)
Standard Deviation 17.76
|
76.3 TSAT Percentage (%)
Standard Deviation 40.99
|
|
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
Change from Baseline to Week 12
|
-27.6 TSAT Percentage (%)
Standard Deviation 20.37
|
-46.8 TSAT Percentage (%)
Standard Deviation 23.61
|
-1.3 TSAT Percentage (%)
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8 and Week 12Population: The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.
Sparse sampling for determination of VIT-2763 plasma concentration following multiple dosing was obtained from pre-dose trough to 3 hours or 4 hours post-dose at selected study visits. Pharmacokinetics parameters (Cmax, clearance, distribution volume, area under the curve (AUC) were not calculated for the study.
Outcome measures
| Measure |
VIT-2763 QD
n=9 Participants
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 Participants
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 3 1 hour post-dose
|
796.5 nanograms per milliliter (ng/mL)
Standard Deviation 508.2
|
609.6 nanograms per milliliter (ng/mL)
Standard Deviation 455.2
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 3 4 hours post-dose
|
222.3 nanograms per milliliter (ng/mL)
Standard Deviation 73.1
|
411.0 nanograms per milliliter (ng/mL)
Standard Deviation 269.5
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 6 pre-dose
|
17.2 nanograms per milliliter (ng/mL)
Standard Deviation 10.2
|
114.4 nanograms per milliliter (ng/mL)
Standard Deviation 78.2
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 6 1 hour post-dose
|
986.2 nanograms per milliliter (ng/mL)
Standard Deviation 796.7
|
483.5 nanograms per milliliter (ng/mL)
Standard Deviation 247.3
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 6 3 hours post-dose
|
578.2 nanograms per milliliter (ng/mL)
Standard Deviation 494.5
|
544.3 nanograms per milliliter (ng/mL)
Standard Deviation 337.5
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 7 pre-dose
|
15.5 nanograms per milliliter (ng/mL)
Standard Deviation 6.6
|
111.0 nanograms per milliliter (ng/mL)
Standard Deviation 61.9
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 7 1 hour post-dose
|
751.7 nanograms per milliliter (ng/mL)
Standard Deviation 682.3
|
692.2 nanograms per milliliter (ng/mL)
Standard Deviation 470.2
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 7 4 hours post-dose
|
295.5 nanograms per milliliter (ng/mL)
Standard Deviation 209.5
|
384.3 nanograms per milliliter (ng/mL)
Standard Deviation 200.9
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 8 pre-dose
|
361.5 nanograms per milliliter (ng/mL)
Standard Deviation 579.2
|
136.0 nanograms per milliliter (ng/mL)
Standard Deviation 76.8
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 8 1 hour post-dose
|
894.1 nanograms per milliliter (ng/mL)
Standard Deviation 670.3
|
650.6 nanograms per milliliter (ng/mL)
Standard Deviation 474.5
|
—
|
|
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
Visit 8 3 hours post-dose
|
684.0 nanograms per milliliter (ng/mL)
Standard Deviation 405.5
|
569.9 nanograms per milliliter (ng/mL)
Standard Deviation 343.1
|
—
|
Adverse Events
VIT-2763 QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VIT-2763 BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VIT-2763 QD
n=9 participants at risk
Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
The study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.
QD = once a day
|
VIT-2763 BID
n=12 participants at risk
Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.
Participants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.
BID = twice a day
|
Placebo
n=4 participants at risk
Participants who received twice a day hard capsules of placebo, during 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Blood and lymphatic system disorders
Haemolysis
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
25.0%
1/4 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Eye disorders
Photopsia
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Eye disorders
Vitreous floaters
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
16.7%
2/12 • Number of events 2 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
16.7%
2/12 • Number of events 2 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
25.0%
1/4 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
General disorders
Pyrexia
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
16.7%
2/12 • Number of events 2 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Hepatobiliary disorders
Jaundice
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
25.0%
1/4 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
25.0%
1/4 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/12 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
25.0%
1/4 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
8.3%
1/12 • Number of events 1 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
0.00%
0/4 • up to 20 weeks (all visits/phone calls through study completion are considered)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER