Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Pharmacokinetics - Cmax |
Maximum plasma concentration (Cmax) of ß-D-N-4-hydroxycytidine (NHC) |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - tmax |
Time to reach Cmax (tmax) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - AUC0-t |
Area under the plasma concentration-time curve from time 0 to t (AUC0-t) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - AUC0-inf |
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - AUCextr |
Extrapolated AUC of NHC, defined as (AUC0-inf - AUC0-t)/AUC0-inf |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - t1/2 |
Elimination half-life (t1/2) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - kel |
Elimination constant (kel) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Pharmacokinetics - MRT |
Mean residence time (MRT) of NHC |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Bioequivalence - ratio of Cmax |
Ratio of geometric mean Cmax for NHC after intake of R or T (with 90% confidence intervals) |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Bioequivalence - ratio of AUC0-t |
Ratio of geometric mean AUC0-t for NHC after intake of R or T (with 90% confidence intervals) |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Primary |
Bioequivalence - ratio of AUC0-inf |
Ratio of geometric mean AUC0-inf for NHC after intake of R or T (with 90% confidence intervals) |
From 0 to 24 hours (Day 1-2 and Day 8-9) |
|
Secondary |
Safety and Tolerability: adverse event (AE) number and frequency |
Number and frequency of adverse events (AEs) or serious AEs (SAEs) |
From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: adverse event (AE) characteristics |
Description and severity of AEs or serious AEs (SAEs), concomitant therapy for AEs/SAEs, causal relationship, outcomes. |
From the screening (and signing informed consent form) to Day 14 of the study or to an early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: vital signs - systolic blood pressure (SBP) |
SBP, mmHg |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: vital signs - diastolic blood pressure (DBP) |
DBP, mmHg |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: vital signs - respiratory rate (RR) |
RR, breaths per minute |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: vital signs - heart rate (HR) |
HR, beats per minute |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: vital signs - body temperature |
Body temperature, centigrade scale |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: physical examination results |
Physical examination results |
Screening, from Day 0 to Day 2, from Day 7 to Day 9, and/or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - color |
Color of the urine |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - transparency |
Transparency of the urine |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - pH |
pH of the urine |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - specific gravity |
Specific gravity of the urine |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - nitrites |
Nitrites in the urine (+/-) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - protein |
Protein in the urine (g/L) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - glucose |
Glucose in the urine (mmol/L) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - ketones |
Ketones in the urine (mmol/L) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - urobilinogen |
Urobilinogen in the urine (mmol/L) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis - bilirubin |
Bilirubin in the urine (+/-) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - red blood cells |
Red blood cells in the urine (number in sight) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - white blood cells |
White blood cells in the urine (number in sight) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - cylinders (except hyaline) |
Cylinders (except hyaline) in the urine (number in sight) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: urinalysis (microscopy) - bacteria |
Bacteria in the urine (number in sight) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - hemoglobin |
Hemoglobin, g/dL |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - red blood cells |
Red blood cells, 10^6/uL |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - hematocrit |
Hematocrit, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - platelets |
Platelets, 10^3/uL |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - white blood cells |
White blood cells, 10^3/uL |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - erythrocyte sedimentation rate |
Erythrocyte sedimentation rate, mm per hour |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - neutrophils |
Neutrophils, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - lymphocytes |
Lymphocytes, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - eosinophils |
Eosinophils, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - monocytes |
Monocytes, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: complete blood count - basophils |
Basophils, % |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - total protein |
Total protein in blood serum, g/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - creatinine |
Creatinine in blood serum, umol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - urea |
Urea in blood serum, mmol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - glucose |
Glucose in blood serum, mmol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - total bilirubin |
Total bilirubin in blood serum, umol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - direct bilirubin |
Direct bilirubin in blood serum, umol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - total cholesterol |
Total cholesterol in blood serum, mmol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - triglycerides |
Triglycerides in blood serum, mmol/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - alanine transaminase (ALT) |
ALT in blood serum, U/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - aspartate transaminase (AST) |
AST in blood serum, U/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: blood test results - alkaline phosphatase (ALP) |
ALP in blood serum, U/L |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|
Secondary |
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc) |
12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms) |
Screening, Day 3, Day 9 or on early termination visit within the time frame of the study (from Day 0 to Day 14) |
|