Beta-Thalassemia, Non-transfusion-dependent Thalassemia
Conditions
Keywords
Beta-Thalassemia
Brief summary
This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).
Detailed description
The study includes a 12-week treatment period and a safety follow-up period of 4 weeks. About 36 participants (adults and adolescents) are expected to take part in this study at a number of different institutions internationally. Adult Participants (Cohort I) will be randomized to receive either VIT-2763 once daily (QD) or twice daily (BID) or placebo, at a dose of 120 mg or 60mg depending on their body weight. Following cohort I review, adolescent participants (Cohort II) will be randomized to the same study arms with the same interventions. The study medication will be given as oral capsules, containing 60 mg of VIT-2763 or placebo.
Interventions
DRUGVIT-2763 once a day (QD)
Participants will receive VIT-2763 QD at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.
DRUGVIT-2763 twice a day (BID)
Participants will receive VIT-2763 BID at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.
DRUGPlacebo
Participants will receive hard capsules of Placebo, twice a day.
Sponsors
Labcorp Corporation of America Holdings, Inc
Vifor (International) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will receive a randomisation number using a validated centralised procedure (IWRS) that automates the random assignment of treatment groups to randomisation numbers. The randomisation plan will be kept strictly confidential, accessible only to authorised persons, until the time of unblinding. The study drugs (VIT-2763 or placebo) are provided in identical white opaque hard capsules in packaging of identical appearance.
Intervention model description
Multiple dose, multicenter, double-blind, placebo-controlled parallel group study in adult and adolescent male and female subjects with non-transfusion dependent thalassemia (NTDT)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of NTDT, including a β-thalassemia intermedia-phenotype. * NTDT is defined as subjects having received less than 5 units of red blood cells (RBCs) during the 24-week period prior to randomisation/first drug administration of VIT-2763 or placebo (Day 1; 1 unit is defined as 200 to 350 ml of transfused packed RBCs and last RBC transfusion must have been received at east 14 days prior to randomisation). * Male and female adult NTDT subjects, 18-65 years of age inclusive (Cohort I only) at time of screening. * Male and female adolescent NTDT subjects, 12-17 years of age inclusive (Cohort II only) at time of screening. * Subjects must have a mean baseline hemoglobin (Hb) equal to or lower than 11 g/dl, based on at least 2 consecutive measurements with at least 1 week apart within 6 weeks prior to randomisation/baseline.
Exclusion criteria
* Documented diagnosis of transfusion dependent thalassemia (TDT), including a beta-thalassemia major phenotype (including β0/β0, β+/β+, β0/β+ genotype), and mixed compound heterozygous for sickling phenotype variants such as Hb S/β- thalassemia, or transfusion dependent non-deletional Hb H disease (i.e., Hb constant spring) or Hb C disease. * Subjects on concomitant iron chelation therapy (ICT) or subjects on prior ICT when discontinued less than 4 weeks prior randomisation. If ICT was discontinued at least 4 weeks prior randomization the subject is eligible. * ICT naïve subjects or subjects who discontinued ICT therapy at least 6 months before the screening visit with serum ferritin lower than 150 ng/ml and/or documented liver iron concentration (LIC) equal to or lower than 1 mg/g liver dry weight assessed through magnetic resonance imaging (MRI), or subjects on prior ICT with serum ferritin lower than 300 ng/ml and/or documented LIC lower than 3 mg/g liver dry weight assessed through MRI. * Subjects with transferrin saturation (TSAT) less than 30%. * Subjects with documented LIC greater than 15 mg/g liver dry weight assessed through MRI, or a documented myocardial T2\* less than 20 ms, if available per local practice and retrieved within 24 months prior to randomization. * Adult or adolescent subjects with body weight lower than 40.0 kg or greater than 100 kg at screening. * Chronic liver disease and/or alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) above 3-fold the upper limit of normal (ULN) range at screening. * Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2 (according to chronic kidney disease classification Stage 4 or higher), and/or significant albuminuria greater than 30 mg/mmol. eGFR should be estimated according to Chronic Kidney Disease Epidemiology Collaboration formula (CKI-EPI) in adults, and Schwartz formula in adolescents. * Newly diagnosed folate deficiency anemia and/or Vitamin B12 megaloblastic anemia. Subjects with known folate deficiency anemia and/or Vitamin B12 megaloblastic anemia who are on at least 12 weeks stable replacement therapy are eligible. * Any history or clinically important finding of cardiac disorders, such as clinically relevant cardiac arrhythmia, cardiomyopathy, coronary disease, valve disorder, or heart failure according to New York Heart Association classification 3-4. * Subjects with history of partial or total splenectomy within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline to Week 16 | 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. |
| Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | From baseline to Week 12 | Summary of the values by visit from baseline and changes from baseline by post-baseline visit. |
| Changes in the Heart Rate | From baseline to Week 12 | Summary of the values by visit from baseline and changes from baseline by post-baseline visit. |
| Changes in 12-lead Electrocardiogram (ECG) Parameters | From baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Serum Iron | From baseline to Week 12 | 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. |
| Change From Baseline in Serum Ferritin | From baseline to Week 12 | 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. |
| Change From Baseline in Serum Transferrin | From baseline to Week 12 | 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. |
| Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | From baseline to Week 12 | 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. |
| Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Baseline, Week 4, Week 8 and Week 12 | 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. |
Countries
Greece, Israel, Italy, Lebanon, Thailand
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9 |
| 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 | 12 |
| Placebo Participants who received twice a day hard capsules of placebo, during 12 weeks. | 4 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | VIT-2763 QD | VIT-2763 BID | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 12 Participants | 4 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 11 Participants | 4 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 3 Participants | 16 Participants |
| Region of Enrollment Greece | 3 participants | 3 participants | 1 participants | 7 participants |
| Region of Enrollment Israel | 0 participants | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Italy | 0 participants | 3 participants | 0 participants | 3 participants |
| Region of Enrollment Lebanon | 1 participants | 2 participants | 0 participants | 3 participants |
| Region of Enrollment Thailand | 5 participants | 3 participants | 1 participants | 9 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 | 0 / 4 |
| other Total, other adverse events | 6 / 9 | 7 / 12 | 3 / 4 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 | 0 / 4 |
Outcome results
Primary
Changes in 12-lead Electrocardiogram (ECG) Parameters
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.
Time frame: From baseline to Week 12
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 4 | -2.0 milliseconds (ms) | Standard Deviation 24.74 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 2 | -32.1 milliseconds (ms) | Standard Deviation 146.7 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 8 | -3.0 milliseconds (ms) | Standard Deviation 15.99 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 4 | -4.3 milliseconds (ms) | Standard Deviation 18.85 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 2 | 757.3 milliseconds (ms) | Standard Deviation 120.25 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 12 | 94.3 milliseconds (ms) | Standard Deviation 27.31 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 1 | 159.2 milliseconds (ms) | Standard Deviation 22.9 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 1 | 3.8 milliseconds (ms) | Standard Deviation 82.82 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 12 | 0.3 milliseconds (ms) | Standard Deviation 20.64 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 4 | 401.3 milliseconds (ms) | Standard Deviation 64.21 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline | 371.7 milliseconds (ms) | Standard Deviation 76.41 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 8 | 161.2 milliseconds (ms) | Standard Deviation 19.34 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 1 | 793.2 milliseconds (ms) | Standard Deviation 105.35 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline 2h post-dose | 385.7 milliseconds (ms) | Standard Deviation 50.89 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline | 158.3 milliseconds (ms) | Standard Deviation 25.14 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Baseline 2h post-dose | 14.0 milliseconds (ms) | Standard Deviation 61 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 2 | 17.4 milliseconds (ms) | Standard Deviation 77.84 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 1 | 394.1 milliseconds (ms) | Standard Deviation 47.36 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 8 | 2.9 milliseconds (ms) | Standard Deviation 17.05 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline 2h post-dose | 781.2 milliseconds (ms) | Standard Deviation 155.21 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 1 | 22.4 milliseconds (ms) | Standard Deviation 57.2 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 12 | 10.8 milliseconds (ms) | Standard Deviation 37.94 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline | 789.4 milliseconds (ms) | Standard Deviation 128.89 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 2 | 384.0 milliseconds (ms) | Standard Deviation 55.52 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 2 | 420.8 milliseconds (ms) | Standard Deviation 42.28 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 12 | 380.9 milliseconds (ms) | Standard Deviation 59.97 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 2 | 12.3 milliseconds (ms) | Standard Deviation 76.14 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 1 | 0.9 milliseconds (ms) | Standard Deviation 16.59 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 8 | 18.0 milliseconds (ms) | Standard Deviation 69.6 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 4 | 370.1 milliseconds (ms) | Standard Deviation 67.13 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 1 | 22.3 milliseconds (ms) | Standard Deviation 65.53 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 4 | -1.6 milliseconds (ms) | Standard Deviation 23.07 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 12 | 2.2 milliseconds (ms) | Standard Deviation 19.5 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 8 | 389.7 milliseconds (ms) | Standard Deviation 39.2 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 12 | 9.2 milliseconds (ms) | Standard Deviation 33.53 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 1 | 425.7 milliseconds (ms) | Standard Deviation 37.25 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline | 94.0 milliseconds (ms) | Standard Deviation 18.73 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 12 | 414.1 milliseconds (ms) | Standard Deviation 53.4 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline 2h post-dose | 94.3 milliseconds (ms) | Standard Deviation 20.21 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 2 | 167.6 milliseconds (ms) | Standard Deviation 26.49 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline 2h post-dose | 419.3 milliseconds (ms) | Standard Deviation 36.58 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline | 403.3 milliseconds (ms) | Standard Deviation 80.48 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 1 | 98.4 milliseconds (ms) | Standard Deviation 23.16 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 8 | 22.7 milliseconds (ms) | Standard Deviation 80.36 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 12 | -8.8 milliseconds (ms) | Standard Deviation 115.95 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 1 | 4.4 milliseconds (ms) | Standard Deviation 14.75 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 2 | 9.2 milliseconds (ms) | Standard Deviation 27.64 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 12 | 780.7 milliseconds (ms) | Standard Deviation 140.88 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 2 | 94.0 milliseconds (ms) | Standard Deviation 29.01 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline 2h post-dose | 161.2 milliseconds (ms) | Standard Deviation 21.28 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 8 | -24.4 milliseconds (ms) | Standard Deviation 116.42 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 2 | 0.0 milliseconds (ms) | Standard Deviation 23.04 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 8 | 426.0 milliseconds (ms) | Standard Deviation 30.12 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 8 | 765.0 milliseconds (ms) | Standard Deviation 91.52 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 4 | 92.3 milliseconds (ms) | Standard Deviation 23.32 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 4 | 154.0 milliseconds (ms) | Standard Deviation 26.49 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 4 | -5.8 milliseconds (ms) | Standard Deviation 62.11 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 4 | -1.7 milliseconds (ms) | Standard Deviation 11.16 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 12 | 160.6 milliseconds (ms) | Standard Deviation 19.55 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 4 | 783.7 milliseconds (ms) | Standard Deviation 110.55 |
| VIT-2763 QD | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 8 | 91.0 milliseconds (ms) | Standard Deviation 24.72 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 12 | 20.0 milliseconds (ms) | Standard Deviation 73.46 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline 2h post-dose | 155.1 milliseconds (ms) | Standard Deviation 17.98 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Baseline 2h post-dose | 6.3 milliseconds (ms) | Standard Deviation 16.45 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 1 | 153.0 milliseconds (ms) | Standard Deviation 14.12 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 1 | 4.7 milliseconds (ms) | Standard Deviation 12.71 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 2 | 153.0 milliseconds (ms) | Standard Deviation 17.87 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 2 | 5.5 milliseconds (ms) | Standard Deviation 13.56 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 4 | 154.2 milliseconds (ms) | Standard Deviation 21.19 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 4 | 8.1 milliseconds (ms) | Standard Deviation 15.48 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 8 | 153.5 milliseconds (ms) | Standard Deviation 20.61 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 8 | 7.1 milliseconds (ms) | Standard Deviation 12.66 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 12 | 156.6 milliseconds (ms) | Standard Deviation 14.47 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 12 | 11.5 milliseconds (ms) | Standard Deviation 14.25 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline | 88.8 milliseconds (ms) | Standard Deviation 19.17 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline 2h post-dose | 95.8 milliseconds (ms) | Standard Deviation 10.96 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Baseline 2h post-dose | 7.0 milliseconds (ms) | Standard Deviation 14.39 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 1 | 96.1 milliseconds (ms) | Standard Deviation 11.27 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 1 | 7.3 milliseconds (ms) | Standard Deviation 13.45 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 2 | 96.3 milliseconds (ms) | Standard Deviation 14.13 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 2 | 7.6 milliseconds (ms) | Standard Deviation 17.96 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 4 | 92.6 milliseconds (ms) | Standard Deviation 15.11 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 4 | 6.0 milliseconds (ms) | Standard Deviation 16.76 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 8 | 94.9 milliseconds (ms) | Standard Deviation 18.27 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 8 | 7.4 milliseconds (ms) | Standard Deviation 28.52 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 12 | 84.8 milliseconds (ms) | Standard Deviation 18.66 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 12 | -2.7 milliseconds (ms) | Standard Deviation 23.7 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline | 374.2 milliseconds (ms) | Standard Deviation 21.78 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline 2h post-dose | 376.8 milliseconds (ms) | Standard Deviation 22.25 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Baseline 2h post-dose | 2.6 milliseconds (ms) | Standard Deviation 21.49 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 1 | 374.8 milliseconds (ms) | Standard Deviation 33.12 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 1 | 0.7 milliseconds (ms) | Standard Deviation 28.96 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 2 | 367.0 milliseconds (ms) | Standard Deviation 24.68 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 2 | -7.2 milliseconds (ms) | Standard Deviation 27.61 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 4 | 373.6 milliseconds (ms) | Standard Deviation 21.22 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 4 | 0.9 milliseconds (ms) | Standard Deviation 24.94 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 8 | 379.4 milliseconds (ms) | Standard Deviation 25.08 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 8 | 4.6 milliseconds (ms) | Standard Deviation 22.59 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 12 | 364.2 milliseconds (ms) | Standard Deviation 36.22 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 12 | -10.5 milliseconds (ms) | Standard Deviation 33.69 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline | 801.4 milliseconds (ms) | Standard Deviation 95.56 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline 2h post-dose | 805.5 milliseconds (ms) | Standard Deviation 119.36 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Baseline 2h post-dose | 4.1 milliseconds (ms) | Standard Deviation 112.91 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 1 | 864.9 milliseconds (ms) | Standard Deviation 149.33 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 2 | 830.1 milliseconds (ms) | Standard Deviation 138.34 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 2 | 28.7 milliseconds (ms) | Standard Deviation 117.34 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 4 | 829.8 milliseconds (ms) | Standard Deviation 154.72 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 4 | 34.1 milliseconds (ms) | Standard Deviation 137.64 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 8 | 810.1 milliseconds (ms) | Standard Deviation 138.16 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 8 | 17.2 milliseconds (ms) | Standard Deviation 108.39 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 12 | 812.9 milliseconds (ms) | Standard Deviation 93.89 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline | 147.6 milliseconds (ms) | Standard Deviation 20.05 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline | 400.5 milliseconds (ms) | Standard Deviation 22.76 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline 2h post-dose | 410.1 milliseconds (ms) | Standard Deviation 25.34 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Baseline 2h post-dose | 9.6 milliseconds (ms) | Standard Deviation 22.6 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 1 | -3.3 milliseconds (ms) | Standard Deviation 24.92 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 2 | 393.3 milliseconds (ms) | Standard Deviation 28.9 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 2 | -7.2 milliseconds (ms) | Standard Deviation 27.52 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 4 | 401.8 milliseconds (ms) | Standard Deviation 27.41 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 4 | 2.1 milliseconds (ms) | Standard Deviation 24.41 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 8 | 399.6 milliseconds (ms) | Standard Deviation 27.17 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 8 | 0.3 milliseconds (ms) | Standard Deviation 26.86 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 12 | 391.4 milliseconds (ms) | Standard Deviation 42.91 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 12 | -8.0 milliseconds (ms) | Standard Deviation 37.96 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 1 | 63.5 milliseconds (ms) | Standard Deviation 137.59 |
| VIT-2763 BID | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 1 | 397.3 milliseconds (ms) | Standard Deviation 30.44 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 4 | -25.0 milliseconds (ms) | Standard Deviation 54.02 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 4 | 378.0 milliseconds (ms) | Standard Deviation 36.51 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 4 | 825.8 milliseconds (ms) | Standard Deviation 96.08 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 4 | 94.3 milliseconds (ms) | Standard Deviation 8.1 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 8 | 404.3 milliseconds (ms) | Standard Deviation 19.86 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 4 | -51.8 milliseconds (ms) | Standard Deviation 111.05 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 2 | -28.0 milliseconds (ms) | Standard Deviation 61.36 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 2 | 185.5 milliseconds (ms) | Standard Deviation 4.43 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 8 | 844.8 milliseconds (ms) | Standard Deviation 135.47 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 2 | 91.3 milliseconds (ms) | Standard Deviation 12.09 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline 2h post-dose | 175.0 milliseconds (ms) | Standard Deviation 14.07 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 8 | -32.8 milliseconds (ms) | Standard Deviation 152.45 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 1 | -21.3 milliseconds (ms) | Standard Deviation 65.76 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 8 | -12.5 milliseconds (ms) | Standard Deviation 4.51 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 12 | 878.3 milliseconds (ms) | Standard Deviation 133.7 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 1 | 98.0 milliseconds (ms) | Standard Deviation 16.57 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 1 | 13.8 milliseconds (ms) | Standard Deviation 25.67 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 12 | 0.8 milliseconds (ms) | Standard Deviation 172.81 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Baseline 2h post-dose | -34.3 milliseconds (ms) | Standard Deviation 55.27 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Baseline 2h post-dose | -65.0 milliseconds (ms) | Standard Deviation 196.09 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline | 416.8 milliseconds (ms) | Standard Deviation 17.46 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline 2h post-dose | 85.0 milliseconds (ms) | Standard Deviation 11.6 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 12 | 405.3 milliseconds (ms) | Standard Deviation 25.71 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Baseline 2h post-dose | 407.3 milliseconds (ms) | Standard Deviation 13.05 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Baseline | 119.3 milliseconds (ms) | Standard Deviation 50.12 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 1 | 189.5 milliseconds (ms) | Standard Deviation 18.72 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Baseline 2h post-dose | -9.5 milliseconds (ms) | Standard Deviation 6.76 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 12 | 7.0 milliseconds (ms) | Standard Deviation 36.09 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 1 | 406.8 milliseconds (ms) | Standard Deviation 26.02 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 12 | 182.8 milliseconds (ms) | Standard Deviation 11.98 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Baseline | 175.8 milliseconds (ms) | Standard Deviation 38.92 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 1 | -10.0 milliseconds (ms) | Standard Deviation 20.38 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 8 | 10.0 milliseconds (ms) | Standard Deviation 32.86 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 12 | -11.5 milliseconds (ms) | Standard Deviation 10.63 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 2 | 402.0 milliseconds (ms) | Standard Deviation 30.3 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 4 | -42.8 milliseconds (ms) | Standard Deviation 61.5 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 8 | 185.8 milliseconds (ms) | Standard Deviation 10.14 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 8 | 381.8 milliseconds (ms) | Standard Deviation 37.99 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 2 | -42.5 milliseconds (ms) | Standard Deviation 61.87 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Baseline 2h post-dose | -0.8 milliseconds (ms) | Standard Deviation 38.59 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 8 | -39.0 milliseconds (ms) | Standard Deviation 64.59 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 2 | 378.3 milliseconds (ms) | Standard Deviation 27.89 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 2 | -14.8 milliseconds (ms) | Standard Deviation 14.52 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 12 | 388.3 milliseconds (ms) | Standard Deviation 42.85 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 4 | 9.3 milliseconds (ms) | Standard Deviation 33.42 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 12 | -32.5 milliseconds (ms) | Standard Deviation 72.06 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Week 1 | -39.3 milliseconds (ms) | Standard Deviation 71.63 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 12 | -27.5 milliseconds (ms) | Standard Deviation 60.69 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline | 877.5 milliseconds (ms) | Standard Deviation 114.65 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Week 1 | 381.5 milliseconds (ms) | Standard Deviation 32.18 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Week 4 | 402.8 milliseconds (ms) | Standard Deviation 23.63 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Baseline 2h post-dose | 812.5 milliseconds (ms) | Standard Deviation 124.38 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Change from Baseline to Baseline 2h post-dose | -41.3 milliseconds (ms) | Standard Deviation 68.3 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Week 4 | 185.0 milliseconds (ms) | Standard Deviation 7.39 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline | 420.8 milliseconds (ms) | Standard Deviation 48.75 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QT interval - Baseline 2h post-dose | 379.5 milliseconds (ms) | Standard Deviation 30.17 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 1 | 826.5 milliseconds (ms) | Standard Deviation 96.57 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 12 | 91.8 milliseconds (ms) | Standard Deviation 10.59 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 1 | -51.0 milliseconds (ms) | Standard Deviation 98.8 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Change from Baseline to Week 8 | -26.0 milliseconds (ms) | Standard Deviation 60.02 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QTcF interval - Change from Baseline to Week 4 | -14.0 milliseconds (ms) | Standard Deviation 7.07 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Week 2 | 833.8 milliseconds (ms) | Standard Deviation 16.01 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | QRS duration - Week 8 | 93.3 milliseconds (ms) | Standard Deviation 10.81 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | PR interval - Change from Baseline to Week 2 | 9.8 milliseconds (ms) | Standard Deviation 37.56 |
| Placebo | Changes in 12-lead Electrocardiogram (ECG) Parameters | RR interval - Change from Baseline to Week 2 | -43.8 milliseconds (ms) | Standard Deviation 103.92 |
Primary
Changes in the Heart Rate
Summary of the values by visit from baseline and changes from baseline by post-baseline visit.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Changes in the Heart Rate | Change from Baseline to Week 12 | -0.56 Pulse Rate (bpm) | Standard Deviation 8.719 |
| VIT-2763 QD | Changes in the Heart Rate | Week 12 | 81.44 Pulse Rate (bpm) | Standard Deviation 9.002 |
| VIT-2763 QD | Changes in the Heart Rate | Baseline | 82.00 Pulse Rate (bpm) | Standard Deviation 12.135 |
| VIT-2763 QD | Changes in the Heart Rate | Week 2 | 83.56 Pulse Rate (bpm) | Standard Deviation 12.856 |
| VIT-2763 QD | Changes in the Heart Rate | Change from Baseline to Week 8 | 1.22 Pulse Rate (bpm) | Standard Deviation 6.648 |
| VIT-2763 QD | Changes in the Heart Rate | Change from Baseline to Week 1 | 0.33 Pulse Rate (bpm) | Standard Deviation 6.042 |
| VIT-2763 QD | Changes in the Heart Rate | Change from Baseline to Week 2 | 1.56 Pulse Rate (bpm) | Standard Deviation 10.442 |
| VIT-2763 QD | Changes in the Heart Rate | Week 8 | 83.22 Pulse Rate (bpm) | Standard Deviation 11.322 |
| VIT-2763 QD | Changes in the Heart Rate | Week 1 | 82.33 Pulse Rate (bpm) | Standard Deviation 11.694 |
| VIT-2763 QD | Changes in the Heart Rate | Week 4 | 82.33 Pulse Rate (bpm) | Standard Deviation 14.414 |
| VIT-2763 QD | Changes in the Heart Rate | Change from Baseline to Week 4 | 0.33 Pulse Rate (bpm) | Standard Deviation 8.818 |
| VIT-2763 BID | Changes in the Heart Rate | Week 4 | 77.92 Pulse Rate (bpm) | Standard Deviation 9.83 |
| VIT-2763 BID | Changes in the Heart Rate | Change from Baseline to Week 4 | 0.21 Pulse Rate (bpm) | Standard Deviation 5.541 |
| VIT-2763 BID | Changes in the Heart Rate | Week 8 | 80.27 Pulse Rate (bpm) | Standard Deviation 10.992 |
| VIT-2763 BID | Changes in the Heart Rate | Week 12 | 79.91 Pulse Rate (bpm) | Standard Deviation 8.734 |
| VIT-2763 BID | Changes in the Heart Rate | Change from Baseline to Week 8 | 2.68 Pulse Rate (bpm) | Standard Deviation 9.04 |
| VIT-2763 BID | Changes in the Heart Rate | Baseline | 77.71 Pulse Rate (bpm) | Standard Deviation 10.208 |
| VIT-2763 BID | Changes in the Heart Rate | Change from Baseline to Week 12 | 2.32 Pulse Rate (bpm) | Standard Deviation 9.419 |
| VIT-2763 BID | Changes in the Heart Rate | Week 2 | 75.83 Pulse Rate (bpm) | Standard Deviation 9.953 |
| VIT-2763 BID | Changes in the Heart Rate | Change from Baseline to Week 2 | -1.88 Pulse Rate (bpm) | Standard Deviation 8.263 |
| VIT-2763 BID | Changes in the Heart Rate | Change from Baseline to Week 1 | 2.63 Pulse Rate (bpm) | Standard Deviation 5.859 |
| VIT-2763 BID | Changes in the Heart Rate | Week 1 | 80.33 Pulse Rate (bpm) | Standard Deviation 9.875 |
| Placebo | Changes in the Heart Rate | Change from Baseline to Week 12 | 0.50 Pulse Rate (bpm) | Standard Deviation 6.137 |
| Placebo | Changes in the Heart Rate | Baseline | 73.75 Pulse Rate (bpm) | Standard Deviation 5.56 |
| Placebo | Changes in the Heart Rate | Week 1 | 70.75 Pulse Rate (bpm) | Standard Deviation 6.449 |
| Placebo | Changes in the Heart Rate | Change from Baseline to Week 1 | -3.00 Pulse Rate (bpm) | Standard Deviation 5.715 |
| Placebo | Changes in the Heart Rate | Week 12 | 74.25 Pulse Rate (bpm) | Standard Deviation 4.193 |
| Placebo | Changes in the Heart Rate | Week 2 | 75.00 Pulse Rate (bpm) | Standard Deviation 8.756 |
| Placebo | Changes in the Heart Rate | Change from Baseline to Week 2 | 1.25 Pulse Rate (bpm) | Standard Deviation 3.775 |
| Placebo | Changes in the Heart Rate | Week 4 | 73.25 Pulse Rate (bpm) | Standard Deviation 3.775 |
| Placebo | Changes in the Heart Rate | Change from Baseline to Week 4 | -0.50 Pulse Rate (bpm) | Standard Deviation 1.915 |
| Placebo | Changes in the Heart Rate | Week 8 | 72.50 Pulse Rate (bpm) | Standard Deviation 5.196 |
| Placebo | Changes in the Heart Rate | Change from Baseline to Week 8 | -1.25 Pulse Rate (bpm) | Standard Deviation 7.411 |
Primary
Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Summary of the values by visit from baseline and changes from baseline by post-baseline visit.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline | 114.2 millimeters of mercury (mmHg) | Standard Deviation 11.62 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 6.6 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 4 | 112.0 millimeters of mercury (mmHg) | Standard Deviation 11.2 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 1 | 66.44 millimeters of mercury (mmHg) | Standard Deviation 6.71 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Baseline | 65.94 millimeters of mercury (mmHg) | Standard Deviation 10.088 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 10.14 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 8 | 0.9 millimeters of mercury (mmHg) | Standard Deviation 9.63 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 8 | 113.8 millimeters of mercury (mmHg) | Standard Deviation 10.54 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 2 | 3.83 millimeters of mercury (mmHg) | Standard Deviation 8.726 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 4 | -2.67 millimeters of mercury (mmHg) | Standard Deviation 9.921 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 8 | 67.18 millimeters of mercury (mmHg) | Standard Deviation 9.174 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 8 | 3.27 millimeters of mercury (mmHg) | Standard Deviation 8.439 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 12 | 67.64 millimeters of mercury (mmHg) | Standard Deviation 9.657 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline | 114.7 millimeters of mercury (mmHg) | Standard Deviation 13.88 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 1 | 116.7 millimeters of mercury (mmHg) | Standard Deviation 10.65 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 1 | 2.0 millimeters of mercury (mmHg) | Standard Deviation 9.72 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 2 | 118.3 millimeters of mercury (mmHg) | Standard Deviation 14.85 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 2 | 3.6 millimeters of mercury (mmHg) | Standard Deviation 8.78 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 4 | 113.9 millimeters of mercury (mmHg) | Standard Deviation 12.41 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 4 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 8.51 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 12 | 112.8 millimeters of mercury (mmHg) | Standard Deviation 11.31 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 12 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 10.85 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Baseline | 65.00 millimeters of mercury (mmHg) | Standard Deviation 10.189 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 1 | 69.33 millimeters of mercury (mmHg) | Standard Deviation 9.921 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 1 | 4.33 millimeters of mercury (mmHg) | Standard Deviation 6.344 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 2 | 68.83 millimeters of mercury (mmHg) | Standard Deviation 11.535 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 4 | 62.33 millimeters of mercury (mmHg) | Standard Deviation 9.069 |
| VIT-2763 BID | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 12 | 3.73 millimeters of mercury (mmHg) | Standard Deviation 6.31 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 4 | -10.0 millimeters of mercury (mmHg) | Standard Deviation 14.72 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 12 | 107.5 millimeters of mercury (mmHg) | Standard Deviation 10.08 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 12 | 62.50 millimeters of mercury (mmHg) | Standard Deviation 3.317 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 2 | 64.00 millimeters of mercury (mmHg) | Standard Deviation 6.055 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 12 | -7.3 millimeters of mercury (mmHg) | Standard Deviation 3.4 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 8 | 0.25 millimeters of mercury (mmHg) | Standard Deviation 7.848 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 12 | -4.00 millimeters of mercury (mmHg) | Standard Deviation 6.88 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Baseline | 66.50 millimeters of mercury (mmHg) | Standard Deviation 7.853 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 8 | 66.75 millimeters of mercury (mmHg) | Standard Deviation 7.5 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 4 | 62.75 millimeters of mercury (mmHg) | Standard Deviation 3.775 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Week 1 | 61.75 millimeters of mercury (mmHg) | Standard Deviation 4.856 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 4 | -3.75 millimeters of mercury (mmHg) | Standard Deviation 5.058 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 2 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 2.83 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 2 | -2.50 millimeters of mercury (mmHg) | Standard Deviation 3 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 4 | 104.8 millimeters of mercury (mmHg) | Standard Deviation 6.85 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 2 | 114.8 millimeters of mercury (mmHg) | Standard Deviation 15.06 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Change from Baseline to Week 1 | -4.75 millimeters of mercury (mmHg) | Standard Deviation 6.185 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 8 | 109.8 millimeters of mercury (mmHg) | Standard Deviation 12.61 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 1 | -10.8 millimeters of mercury (mmHg) | Standard Deviation 10.9 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Week 1 | 104.0 millimeters of mercury (mmHg) | Standard Deviation 8.98 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Change from Baseline to Week 8 | -5.0 millimeters of mercury (mmHg) | Standard Deviation 1.63 |
| Placebo | Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Baseline | 114.8 millimeters of mercury (mmHg) | Standard Deviation 12.97 |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From baseline to Week 16
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIT-2763 QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 Participants |
| VIT-2763 BID | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 7 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
Secondary
Change From Baseline in Calculated Transferrin Saturation (TSAT) )
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.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Baseline | 69.3 TSAT Percentage (%) | Standard Deviation 31.16 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 1 | 36.8 TSAT Percentage (%) | Standard Deviation 24.44 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baselone to Week 1 | -32.6 TSAT Percentage (%) | Standard Deviation 19.55 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 2 | 36.0 TSAT Percentage (%) | Standard Deviation 22.81 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 4 | -24.0 TSAT Percentage (%) | Standard Deviation 18.21 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 8 | 32.3 TSAT Percentage (%) | Standard Deviation 17.48 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 8 | -32.7 TSAT Percentage (%) | Standard Deviation 25.8 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 12 | 36.0 TSAT Percentage (%) | Standard Deviation 25.93 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 12 | -27.6 TSAT Percentage (%) | Standard Deviation 20.37 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 2 | -29.5 TSAT Percentage (%) | Standard Deviation 14.57 |
| VIT-2763 QD | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 4 | 41.0 TSAT Percentage (%) | Standard Deviation 32.27 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 4 | 38.4 TSAT Percentage (%) | Standard Deviation 24.85 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 4 | -38.7 TSAT Percentage (%) | Standard Deviation 27.57 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 1 | 32.2 TSAT Percentage (%) | Standard Deviation 21.44 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 8 | 33.5 TSAT Percentage (%) | Standard Deviation 27.08 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 8 | -47.9 TSAT Percentage (%) | Standard Deviation 29.7 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 12 | 34.8 TSAT Percentage (%) | Standard Deviation 17.76 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Baseline | 79.0 TSAT Percentage (%) | Standard Deviation 24.05 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 2 | -43.2 TSAT Percentage (%) | Standard Deviation 33.23 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baselone to Week 1 | -46.8 TSAT Percentage (%) | Standard Deviation 22.55 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 12 | -46.8 TSAT Percentage (%) | Standard Deviation 23.61 |
| VIT-2763 BID | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 2 | 35.8 TSAT Percentage (%) | Standard Deviation 24.13 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 2 | 71.5 TSAT Percentage (%) | Standard Deviation 33.91 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 12 | -1.3 TSAT Percentage (%) | Standard Deviation 2.31 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 4 | 82.5 TSAT Percentage (%) | Standard Deviation 35 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 4 | -0.8 TSAT Percentage (%) | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Baseline | 83.3 TSAT Percentage (%) | Standard Deviation 33.5 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 12 | 76.3 TSAT Percentage (%) | Standard Deviation 40.99 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 8 | 77.3 TSAT Percentage (%) | Standard Deviation 39.26 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baselone to Week 1 | -26.8 TSAT Percentage (%) | Standard Deviation 28.77 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Week 1 | 56.5 TSAT Percentage (%) | Standard Deviation 30.56 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 8 | -0.3 TSAT Percentage (%) | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Calculated Transferrin Saturation (TSAT) ) | Change from Baseline to Week 2 | -11.8 TSAT Percentage (%) | Standard Deviation 23.5 |
Secondary
Change From Baseline in Serum Ferritin
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.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Week 12 | 465.72 Microgrammes per Litre (ug/L) | Standard Deviation 227.378 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Change from Baseline to Week 2 | 3.29 Microgrammes per Litre (ug/L) | Standard Deviation 60.579 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Change from Baseline to Week 4 | 1.05 Microgrammes per Litre (ug/L) | Standard Deviation 61.638 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Change from Baseline to Week 1 | -10.14 Microgrammes per Litre (ug/L) | Standard Deviation 31.509 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Change from Baseline to Week 12 | -15.84 Microgrammes per Litre (ug/L) | Standard Deviation 66.208 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Baseline | 403.14 Microgrammes per Litre (ug/L) | Standard Deviation 226.315 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Change from Baseline to Week 8 | -11.88 Microgrammes per Litre (ug/L) | Standard Deviation 43.063 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Week 8 | 463.67 Microgrammes per Litre (ug/L) | Standard Deviation 206.646 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Week 2 | 441.34 Microgrammes per Litre (ug/L) | Standard Deviation 269.599 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Week 1 | 416.76 Microgrammes per Litre (ug/L) | Standard Deviation 220.567 |
| VIT-2763 QD | Change From Baseline in Serum Ferritin | Week 4 | 476.60 Microgrammes per Litre (ug/L) | Standard Deviation 282.457 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Week 12 | 927.42 Microgrammes per Litre (ug/L) | Standard Deviation 1478.471 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Baseline | 1133.23 Microgrammes per Litre (ug/L) | Standard Deviation 2119.115 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Change from Baseline to Week 1 | 40.89 Microgrammes per Litre (ug/L) | Standard Deviation 164.466 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Change from Baseline to Week 2 | 23.80 Microgrammes per Litre (ug/L) | Standard Deviation 149.147 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Week 4 | 585.71 Microgrammes per Litre (ug/L) | Standard Deviation 311.224 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Change from Baseline to Week 4 | 89.98 Microgrammes per Litre (ug/L) | Standard Deviation 249.397 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Week 8 | 508.56 Microgrammes per Litre (ug/L) | Standard Deviation 211.366 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Change from Baseline to Week 8 | 52.84 Microgrammes per Litre (ug/L) | Standard Deviation 157.952 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Change from Baseline to Week 12 | -139.23 Microgrammes per Litre (ug/L) | Standard Deviation 626.38 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Week 1 | 471.53 Microgrammes per Litre (ug/L) | Standard Deviation 209.8 |
| VIT-2763 BID | Change From Baseline in Serum Ferritin | Week 2 | 500.79 Microgrammes per Litre (ug/L) | Standard Deviation 230.076 |
| Placebo | Change From Baseline in Serum Ferritin | Change from Baseline to Week 4 | -50.20 Microgrammes per Litre (ug/L) | Standard Deviation 80.958 |
| Placebo | Change From Baseline in Serum Ferritin | Change from Baseline to Week 1 | 5.77 Microgrammes per Litre (ug/L) | Standard Deviation 93.946 |
| Placebo | Change From Baseline in Serum Ferritin | Change from Baseline to Week 12 | 7.25 Microgrammes per Litre (ug/L) | Standard Deviation 57.205 |
| Placebo | Change From Baseline in Serum Ferritin | Week 1 | 445.80 Microgrammes per Litre (ug/L) | Standard Deviation 228.244 |
| Placebo | Change From Baseline in Serum Ferritin | Baseline | 440.03 Microgrammes per Litre (ug/L) | Standard Deviation 321.453 |
| Placebo | Change From Baseline in Serum Ferritin | Week 2 | 411.35 Microgrammes per Litre (ug/L) | Standard Deviation 207.477 |
| Placebo | Change From Baseline in Serum Ferritin | Week 4 | 389.83 Microgrammes per Litre (ug/L) | Standard Deviation 240.553 |
| Placebo | Change From Baseline in Serum Ferritin | Week 8 | 340.23 Microgrammes per Litre (ug/L) | Standard Deviation 165.356 |
| Placebo | Change From Baseline in Serum Ferritin | Change from Baseline to Week 2 | -49.80 Microgrammes per Litre (ug/L) | Standard Deviation 76.867 |
| Placebo | Change From Baseline in Serum Ferritin | Change from Baseline to Week 8 | -9.45 Microgrammes per Litre (ug/L) | Standard Deviation 20.577 |
| Placebo | Change From Baseline in Serum Ferritin | Week 12 | 261.70 Microgrammes per Litre (ug/L) | Standard Deviation 53.033 |
Secondary
Change From Baseline in Serum Transferrin
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.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Change from Baseline to Week 1 | 0.009 Grammes per Litre (g/L) | Standard Deviation 0.1184 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Change from Baseline to Week 2 | -0.014 Grammes per Litre (g/L) | Standard Deviation 0.1516 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Week 4 | 1.708 Grammes per Litre (g/L) | Standard Deviation 0.2672 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Week 1 | 1.610 Grammes per Litre (g/L) | Standard Deviation 0.4557 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Change from Baseline to Week 4 | 0.053 Grammes per Litre (g/L) | Standard Deviation 0.2014 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Baseline 2h post-dose | 1.601 Grammes per Litre (g/L) | Standard Deviation 0.4377 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Week 8 | 1.640 Grammes per Litre (g/L) | Standard Deviation 0.2745 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Change from Baseline to Week 8 | -0.015 Grammes per Litre (g/L) | Standard Deviation 0.0675 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Week 12 | 1.706 Grammes per Litre (g/L) | Standard Deviation 0.1954 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Week 2 | 1.601 Grammes per Litre (g/L) | Standard Deviation 0.5043 |
| VIT-2763 QD | Change From Baseline in Serum Transferrin | Change from Baseline to Week 12 | -0.040 Grammes per Litre (g/L) | Standard Deviation 0.1116 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Week 2 | 1.759 Grammes per Litre (g/L) | Standard Deviation 0.3569 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Change from Baseline to Week 1 | 0.149 Grammes per Litre (g/L) | Standard Deviation 0.1334 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Week 4 | 1.705 Grammes per Litre (g/L) | Standard Deviation 0.3496 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Week 8 | 1.725 Grammes per Litre (g/L) | Standard Deviation 0.3194 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Change from Baseline to Week 2 | 0.087 Grammes per Litre (g/L) | Standard Deviation 0.1429 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Change from Baseline to Week 4 | 0.054 Grammes per Litre (g/L) | Standard Deviation 0.1535 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Week 1 | 1.822 Grammes per Litre (g/L) | Standard Deviation 0.3903 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Week 12 | 1.656 Grammes per Litre (g/L) | Standard Deviation 0.2974 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Change from Baseline to Week 8 | 0.093 Grammes per Litre (g/L) | Standard Deviation 0.1618 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Change from Baseline to Week 12 | 0.100 Grammes per Litre (g/L) | Standard Deviation 0.1044 |
| VIT-2763 BID | Change From Baseline in Serum Transferrin | Baseline 2h post-dose | 1.673 Grammes per Litre (g/L) | Standard Deviation 0.3177 |
| Placebo | Change From Baseline in Serum Transferrin | Change from Baseline to Week 12 | -0.063 Grammes per Litre (g/L) | Standard Deviation 0.1266 |
| Placebo | Change From Baseline in Serum Transferrin | Baseline 2h post-dose | 1.655 Grammes per Litre (g/L) | Standard Deviation 0.3003 |
| Placebo | Change From Baseline in Serum Transferrin | Change from Baseline to Week 1 | 0.028 Grammes per Litre (g/L) | Standard Deviation 0.2419 |
| Placebo | Change From Baseline in Serum Transferrin | Change from Baseline to Week 4 | 0.090 Grammes per Litre (g/L) | Standard Deviation 0.274 |
| Placebo | Change From Baseline in Serum Transferrin | Week 8 | 1.553 Grammes per Litre (g/L) | Standard Deviation 0.2836 |
| Placebo | Change From Baseline in Serum Transferrin | Change from Baseline to Week 8 | -0.120 Grammes per Litre (g/L) | Standard Deviation 0.0854 |
| Placebo | Change From Baseline in Serum Transferrin | Week 12 | 1.610 Grammes per Litre (g/L) | Standard Deviation 0.4784 |
| Placebo | Change From Baseline in Serum Transferrin | Week 1 | 1.683 Grammes per Litre (g/L) | Standard Deviation 0.221 |
| Placebo | Change From Baseline in Serum Transferrin | Week 2 | 1.655 Grammes per Litre (g/L) | Standard Deviation 0.2408 |
| Placebo | Change From Baseline in Serum Transferrin | Change from Baseline to Week 2 | 0.000 Grammes per Litre (g/L) | Standard Deviation 0.1846 |
| Placebo | Change From Baseline in Serum Transferrin | Week 4 | 1.745 Grammes per Litre (g/L) | Standard Deviation 0.3756 |
Secondary
Change From Baseline in Total Serum Iron
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.
Time frame: From baseline to Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Change from Baseline to Week 8 | -11.88 Micromoles per Litre (umol/L) | Standard Deviation 9.627 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Change from Baseline to Week 2 | -9.74 Micromoles per Litre (umol/L) | Standard Deviation 4.707 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Week 12 | 13.72 Micromoles per Litre (umol/L) | Standard Deviation 11.031 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Week 8 | 11.35 Micromoles per Litre (umol/L) | Standard Deviation 7.822 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Week 4 | 13.90 Micromoles per Litre (umol/L) | Standard Deviation 12.222 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Change from Baselines to Week 1 | -11.27 Micromoles per Litre (umol/L) | Standard Deviation 7.158 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Change from Baseline to Week 4 | -9.33 Micromoles per Litre (umol/L) | Standard Deviation 4.659 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Week 1 | 12.54 Micromoles per Litre (umol/L) | Standard Deviation 9.159 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Change from Baseline to Week 12 | -10.54 Micromoles per Litre (umol/L) | Standard Deviation 6.782 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Week 2 | 11.71 Micromoles per Litre (umol/L) | Standard Deviation 8.622 |
| VIT-2763 QD | Change From Baseline in Total Serum Iron | Baseline | 23.81 Micromoles per Litre (umol/L) | Standard Deviation 13.438 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Week 12 | 11.62 Micromoles per Litre (umol/L) | Standard Deviation 6.442 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Baseline | 28.42 Micromoles per Litre (umol/L) | Standard Deviation 9.796 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Week 1 | 11.38 Micromoles per Litre (umol/L) | Standard Deviation 7.693 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Change from Baselines to Week 1 | -17.03 Micromoles per Litre (umol/L) | Standard Deviation 9.611 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Week 2 | 12.99 Micromoles per Litre (umol/L) | Standard Deviation 8.978 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Change from Baseline to Week 2 | -15.43 Micromoles per Litre (umol/L) | Standard Deviation 12.784 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Week 4 | 12.85 Micromoles per Litre (umol/L) | Standard Deviation 7.583 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Change from Baseline to Week 4 | -14.03 Micromoles per Litre (umol/L) | Standard Deviation 8.432 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Week 8 | 11.55 Micromoles per Litre (umol/L) | Standard Deviation 9.651 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Change from Baseline to Week 8 | -17.05 Micromoles per Litre (umol/L) | Standard Deviation 11.936 |
| VIT-2763 BID | Change From Baseline in Total Serum Iron | Change from Baseline to Week 12 | -16.22 Micromoles per Litre (umol/L) | Standard Deviation 10.892 |
| Placebo | Change From Baseline in Total Serum Iron | Change from Baseline to Week 12 | 0.03 Micromoles per Litre (umol/L) | Standard Deviation 2.701 |
| Placebo | Change From Baseline in Total Serum Iron | Week 8 | 26.70 Micromoles per Litre (umol/L) | Standard Deviation 12.04 |
| Placebo | Change From Baseline in Total Serum Iron | Week 2 | 32.48 Micromoles per Litre (umol/L) | Standard Deviation 15.541 |
| Placebo | Change From Baseline in Total Serum Iron | Week 1 | 28.20 Micromoles per Litre (umol/L) | Standard Deviation 17.919 |
| Placebo | Change From Baseline in Total Serum Iron | Change from Baseline to Week 8 | -0.37 Micromoles per Litre (umol/L) | Standard Deviation 3.55 |
| Placebo | Change From Baseline in Total Serum Iron | Week 12 | 27.10 Micromoles per Litre (umol/L) | Standard Deviation 12.856 |
| Placebo | Change From Baseline in Total Serum Iron | Change from Baselines to Week 1 | -2.68 Micromoles per Litre (umol/L) | Standard Deviation 12.365 |
| Placebo | Change From Baseline in Total Serum Iron | Week 4 | 31.08 Micromoles per Litre (umol/L) | Standard Deviation 13.721 |
| Placebo | Change From Baseline in Total Serum Iron | Baseline | 30.88 Micromoles per Litre (umol/L) | Standard Deviation 13.329 |
| Placebo | Change From Baseline in Total Serum Iron | Change from Baseline to Week 4 | 0.20 Micromoles per Litre (umol/L) | Standard Deviation 2.902 |
| Placebo | Change From Baseline in Total Serum Iron | Change from Baseline to Week 2 | 1.60 Micromoles per Litre (umol/L) | Standard Deviation 3.996 |
Secondary
Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time
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.
Time frame: Baseline, Week 4, Week 8 and Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 6 pre-dose | 17.2 nanograms per milliliter (ng/mL) | Standard Deviation 10.2 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 7 pre-dose | 15.5 nanograms per milliliter (ng/mL) | Standard Deviation 6.6 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 8 pre-dose | 361.5 nanograms per milliliter (ng/mL) | Standard Deviation 579.2 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 QD | 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 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 7 1 hour post-dose | 692.2 nanograms per milliliter (ng/mL) | Standard Deviation 470.2 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 3 1 hour post-dose | 609.6 nanograms per milliliter (ng/mL) | Standard Deviation 455.2 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 8 pre-dose | 136.0 nanograms per milliliter (ng/mL) | Standard Deviation 76.8 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 6 1 hour post-dose | 483.5 nanograms per milliliter (ng/mL) | Standard Deviation 247.3 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 6 pre-dose | 114.4 nanograms per milliliter (ng/mL) | Standard Deviation 78.2 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 8 1 hour post-dose | 650.6 nanograms per milliliter (ng/mL) | Standard Deviation 474.5 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 6 3 hours post-dose | 544.3 nanograms per milliliter (ng/mL) | Standard Deviation 337.5 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 8 3 hours post-dose | 569.9 nanograms per milliliter (ng/mL) | Standard Deviation 343.1 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 7 pre-dose | 111.0 nanograms per milliliter (ng/mL) | Standard Deviation 61.9 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 3 4 hours post-dose | 411.0 nanograms per milliliter (ng/mL) | Standard Deviation 269.5 |
| VIT-2763 BID | Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time | Visit 7 4 hours post-dose | 384.3 nanograms per milliliter (ng/mL) | Standard Deviation 200.9 |