Sickle Cell Disease
Conditions
Keywords
anemia, sickle cell disease, vamifeport
Brief summary
The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.
Detailed description
At randomization/baseline, participants are randomized into 3 VIT-2763 dose groups to receive either 60 mg twice daily (BID) (Cohort 1), or 120 mg BID (Cohort 2), or 120 mg 3 times daily (TID) (Cohort 3) and 2 placebo groups (BID, Cohort 4a or TID, Cohort 4b). The expected duration of patient participation is a maximum of 16 weeks, including a non-treatment screening period of up to 4 weeks, and 8-week treatment period, and a 4-week safety follow-up period.
Interventions
DRUGVIT-2763 120 mg
Participants receive 2 capsules of VIT-2763 30 mg in the morning and in the evening, for 8 weeks. Capsules are to be taken orally.
DRUGVIT-2763 360 mg
Participants receive 2 capsules of VIT-2763 60 mg in the morning, in the afternoon and in the evening for 8 weeks. Capsules are to be taken orally.
DRUGVIT-2763 240 mg
Participants receive 2 capsules of VIT-2763 60 mg in the morning and in the evening, for 8 weeks. Capsules are to be taken orally.
DRUGPlacebo BID
Participants receive 2 capsules of placebo in the morning and in the evening, for 8 weeks. Capsules are to be taken orally.
DRUGPlacebo TID
Participants receive 2 capsules of Placebo in the morning, in the afternoon and in the evening, for 8 weeks. Capsules are to be taken orally.
Sponsors
Fortrea
Vifor (International) Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects with confirmed diagnosis of SCD, including only HbS/S or HbS/βT0 genotype. * Subjects who had at least 1 and no more than 10 vaso-occlusive crises (VOC) episodes reported within 12 months prior to screening. * Body weight ≥40 kg and ≤120 kg at screening and baseline. * Subjects on concomitant hydroxyurea must be on a stable dose (mg/kg) for ≥3 months prior to screening Visit V1 * Female subjects of childbearing potential, must have negative pregnancy, must have stopped breastfeeding as of first dose, and must either commit to true abstinence from heterosexual contact or must be willing to use adequate contraceptive precautions. * Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential
Exclusion criteria
* Hb level \<6.0 g/dl or \>10.4 g/dl for female participants and \>11.0 g/dl for male participants, at screening Visit V1 * Having received red blood cell (RBC) transfusion therapy within 4 weeks prior to screening, or ongoing or planned RBC transfusion therapy during the course of the study * Low levels of Ferritin or transferrin saturation or total iron-binding capacity at screening * Subjects being hospitalized for SCD-related events within 14 days before the screening visit * Chronic liver disease or history of liver cirrhosis, and/or high levels of alanine aminotransferase or aspartate aminotransferase at baseline * Low estimated glomerular filtration rate, and/or significant high urinary albumin/creatinine ratio at screening or on chronic dialysis. * Newly diagnosed folate deficiency anemia, which is considered clinically relevant by the Investigator at screening * Any history or clinically important finding of cardiac or pulmonary disorders * Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death * Clinically significant bacterial, fungal, parasitic, or viral infection which requires therapy. Note: A subject meeting this criterion should delay screening and/or enrolment for a minimum of 2 weeks, or if excluded can be re-screened at a later time point. * Concomitant use of certain hormonal contraceptives as defined in the study protocol, are not allowed within 4 weeks prior to screening and until 1 week after the last administration of the study drug and the use of progesterone-only hormonal contraception as the sole measure to prevent pregnancy. * Pregnant or females currently breastfeeding. * History or known concomitant solid tumours and/or haematological malignancies unless resolved in the ≥2 past years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer * Unable to take and absorb oral medications * Acute peptic stomach or duodenal ulcer in the previous 6 months before screening and/or healed after 3 months of treatment. * Uncontrolled hemorrhages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Baseline and after 8 weeks of treatment | Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Baseline and after 8 weeks of treatment | Mean change from baseline in haemolysis markers was measured by direct and total bilirubin. |
| Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase) | Baseline and after 8 weeks of treatment | Mean change from baseline in haemolysis markers was measured by lactate dehydrogenase. |
| Mean Change From Baseline in Haemolysis Marker (Potassium) | Baseline and after 8 weeks of treatment | Mean change from baseline in haemolysis markers was measured by potassium. |
| Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Baseline and after 8 weeks of treatment | Mean change from baseline in haemolysis markers was measured by hemoglobin and haptoglobin. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | From first dose of study drug up to 12 weeks | TEAEs were defined as adverse events (AEs) with an onset date later or on the same date as first investigational medicinal product (IMP) intake. The severity grading was determined according to the Common Terminology Criteria for AEs, where the Common Terminology Criteria grades relate to severity as follows: Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening and Grade 5: Death. |
Countries
France, Greece, Lebanon, United Kingdom, United States
Participant flow
Recruitment details
There were 22 sites initiated for this study in 5 countries (The United Kingdom, Lebanon, Greece, the United States, and France).
Pre-assignment details
A total of 46 participants were screened in this study, of which 28 were screen failures. Out of these 28 participants, 9 were rescreened, and 7 were found eligible for the study. 25 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) Participants received VIT-2763 60 mg (2 x 30 mg capsules), orally, BID for 8 weeks. | 6 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, BID for 8 weeks. | 6 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) Participants received VIT-2763 120 mg (2 x 60 mg capsules), orally, TID for 8 weeks. | 6 |
| Cohort 4: Placebo Participants received placebo capsules, orally, BID or TID for 8 weeks. | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Cohort 4: Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 7.41 | 36.0 years STANDARD_DEVIATION 11.87 | 29.3 years STANDARD_DEVIATION 9.48 | 25.3 years STANDARD_DEVIATION 7.17 | 30.2 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 1 |
| other Total, other adverse events | 4 / 6 | 4 / 6 | 5 / 6 | 5 / 6 | 1 / 1 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 1 / 1 |
Outcome results
Primary
Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin)
Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin.
Time frame: Baseline and after 8 weeks of treatment
Population: This analysis was performed on the intent-to-treat (ITT) population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Baseline | 24.0 micromoles per liter (umol/L) | Standard Deviation 13.51 |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Change at 8 weeks | -4.0 micromoles per liter (umol/L) | Standard Deviation 4.69 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Change at 8 weeks | -5.8 micromoles per liter (umol/L) | Standard Deviation 11.35 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Baseline | 56.4 micromoles per liter (umol/L) | Standard Deviation 43.71 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Baseline | 44.0 micromoles per liter (umol/L) | Standard Deviation 24.48 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Change at 8 weeks | -21.8 micromoles per liter (umol/L) | Standard Deviation 11.62 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Baseline | 31.2 micromoles per liter (umol/L) | Standard Deviation 12.95 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Indirect Bilirubin) | Change at 8 weeks | 0.6 micromoles per liter (umol/L) | Standard Deviation 7.3 |
Secondary
Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin)
Mean change from baseline in haemolysis markers was measured by direct and total bilirubin.
Time frame: Baseline and after 8 weeks of treatment
Population: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Direct Bilirubin | -0.5 umol/L | Standard Deviation 1.29 |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Total Bilirubin | -4.2 umol/L | Standard Deviation 4.76 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Total Bilirubin | -13.2 umol/L | Standard Deviation 16.57 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Direct Bilirubin | -2.0 umol/L | Standard Deviation 2.83 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Direct Bilirubin | -2.5 umol/L | Standard Deviation 7.05 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Total Bilirubin | -26.0 umol/L | Standard Deviation 16 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Direct Bilirubin | -0.4 umol/L | Standard Deviation 1.52 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Direct and Total Bilirubin) | Total Bilirubin | -0.2 umol/L | Standard Deviation 7.08 |
Secondary
Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin)
Mean change from baseline in haemolysis markers was measured by hemoglobin and haptoglobin.
Time frame: Baseline and after 8 weeks of treatment
Population: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure. The 'number analyzed' (n) signifies the number of participants with evaluable data for each specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Haptoglobin | 0.102 grams per liter (g/L) | Standard Deviation 0.2281 |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Hemoglobin | -3.400 grams per liter (g/L) | Standard Deviation 1.4748 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Hemoglobin | -2.067 grams per liter (g/L) | Standard Deviation 5.5142 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Haptoglobin | -0.012 grams per liter (g/L) | Standard Deviation 0.0286 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Hemoglobin | -1.575 grams per liter (g/L) | Standard Deviation 8.4017 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Haptoglobin | 0.528 grams per liter (g/L) | Standard Deviation 0.8312 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Haptoglobin | 0.000 grams per liter (g/L) | Standard Deviation 0 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Hemoglobin and Haptoglobin) | Hemoglobin | 2.733 grams per liter (g/L) | Standard Deviation 9.9933 |
Secondary
Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase)
Mean change from baseline in haemolysis markers was measured by lactate dehydrogenase.
Time frame: Baseline and after 8 weeks of treatment
Population: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase) | -45.8 units per liter (U/L) | Standard Deviation 47.56 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase) | -24.0 units per liter (U/L) | Standard Deviation 6.08 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase) | 7.7 units per liter (U/L) | Standard Deviation 197.5 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Lactate Dehydrogenase) | 47.8 units per liter (U/L) | Standard Deviation 60.06 |
Secondary
Mean Change From Baseline in Haemolysis Marker (Potassium)
Mean change from baseline in haemolysis markers was measured by potassium.
Time frame: Baseline and after 8 weeks of treatment
Population: This analysis was performed on the ITT population. The ITT population consisted of all participants who were randomly assigned to a treatment group under Protocol Version 3.0 or higher. Here, the 'overall number of participants analyzed' (N) signifies the number of participants with evaluable data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Potassium) | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.396 |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Potassium) | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.192 |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Mean Change From Baseline in Haemolysis Marker (Potassium) | -0.22 millimoles per liter (mmol/L) | Standard Deviation 0.319 |
| Cohort 4: Placebo | Mean Change From Baseline in Haemolysis Marker (Potassium) | -0.05 millimoles per liter (mmol/L) | Standard Deviation 0.295 |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs
TEAEs were defined as adverse events (AEs) with an onset date later or on the same date as first investigational medicinal product (IMP) intake. The severity grading was determined according to the Common Terminology Criteria for AEs, where the Common Terminology Criteria grades relate to severity as follows: Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening and Grade 5: Death.
Time frame: From first dose of study drug up to 12 weeks
Population: Analysis was performed on the safety set. The safety set consists of all randomized participants (under Protocol Version 3.0 or higher) who had taken at least one dose of IMP. The participants in the safety set were analyzed based on the treatment they received, regardless of randomization. Data are separately reported for the one participant in the Cohort 2a arm (randomized under Protocol Version 2.0).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Moderate | 3 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Mild | 0 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Severe | 1 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Death | 0 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs related to IMP | 0 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | Any TEAEs | 4 Participants |
| Cohort 1: VIT-2763 60 mg BID (120 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Life threatening | 0 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs related to IMP | 0 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | Any TEAEs | 4 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Mild | 3 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Life threatening | 0 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Death | 0 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Moderate | 1 Participants |
| Cohort 2: VIT-2763 120 mg BID (240 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Severe | 0 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Mild | 2 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Moderate | 1 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Life threatening | 0 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Death | 0 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | Any TEAEs | 5 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Severe | 2 Participants |
| Cohort 3: VIT-2763 120 mg TID (360 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs related to IMP | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Death | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Mild | 3 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs related to IMP | 1 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Severe | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Life threatening | 0 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Moderate | 2 Participants |
| Cohort 4: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | Any TEAEs | 5 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Moderate | 1 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Life threatening | 0 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Death | 0 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | Any TEAEs | 1 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs related to IMP | 0 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Mild | 1 Participants |
| Cohort 2a: VIT-2763 30 mg BID (60 mg/Day) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs Related to IMP and by Severity of TEAEs | TEAEs with severity: Severe | 0 Participants |