Trial Outcomes & Findings for A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers (NCT NCT03887221)
NCT ID: NCT03887221
Last Updated: 2023-03-17
Results Overview
The Cmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
COMPLETED
PHASE1
24 participants
Day 1 and Day 8
2023-03-17
Participant Flow
This single-center study was conducted on 24 Healthy Adult Chinese Volunteers in China from 21 Jun 2021 to 20 Aug 2021.
The screening period was between Day -14 and Day -2. All the study assessments were performed as per the schedule of assessments.
Participant milestones
| Measure |
Cohort 1 (Safinamide 50mg)
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Safinamide 50mg)
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1 (Safinamide 50mg)
n=12 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.8 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 5.38 • n=7 Participants
|
30.4 years
STANDARD_DEVIATION 5.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Chinese
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: All randomised subjects who fulfilled the study protocol requirements in terms of investigational medicinal product (IMP) intake and had evaluable pharmacokinetic (PK) data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The Cmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Maximum Safinamide Plasma Concentration (Cmax)
Day 1
|
411.5 nanogram/milliliter (ng/mL)
Standard Deviation 96.58
|
792.1 nanogram/milliliter (ng/mL)
Standard Deviation 124.0
|
—
|
—
|
|
Maximum Safinamide Plasma Concentration (Cmax)
Day 8
|
465.0 nanogram/milliliter (ng/mL)
Standard Deviation 86.94
|
825.3 nanogram/milliliter (ng/mL)
Standard Deviation 183.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The tmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Time Corresponding to Occurrence of Cmax (Tmax)
Day 1
|
1.500 hour (h)
Interval 0.5 to 3.0
|
1.750 hour (h)
Interval 1.0 to 3.0
|
—
|
—
|
|
Time Corresponding to Occurrence of Cmax (Tmax)
Day 8
|
2.000 hour (h)
Interval 0.5 to 8.0
|
1.508 hour (h)
Interval 1.0 to 3.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The (AUC0-t) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t)
Day 1
|
11560 hour* nanogram/milliliter (h*ng/mL)
Standard Deviation 2170
|
20790 hour* nanogram/milliliter (h*ng/mL)
Standard Deviation 3131
|
—
|
—
|
|
Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t)
Day 8
|
6652 hour* nanogram/milliliter (h*ng/mL)
Standard Deviation 985.5
|
12130 hour* nanogram/milliliter (h*ng/mL)
Standard Deviation 1846
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The (AUC0-24h) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h)
Day 1
|
6291 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 1158
|
11420 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 1727
|
—
|
—
|
|
Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h)
Day 8
|
6649 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 986.3
|
12090 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 1931
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The (Clast/Ct) was determined on Day 1 (after the first dose) of safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Last Quantifiable Concentration (Clast/Ct)
|
23.01 nanogram/milliliter (ng/mL)
Standard Deviation 9.306
|
37.26 nanogram/milliliter (ng/mL)
Standard Deviation 7.483
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Apparent terminal elimination rate constant, calculated, if feasible, from the slope of a log-linear regression using at least 3 last concentration \> lower limit of quantification (LLOQ) points. The Kel was determined on Day 1 (after the first dose) of safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (Kel)
|
0.02967 hour (h)
Standard Deviation 0.004188
|
0.03019 hour (h)
Standard Deviation 0.002283
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Apparent terminal elimination half-life, calculated, if feasible, as ln2/Kel. The t1/2 will be determined on Day 1 (after the first dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Half Life (t1/2)
|
23.79 hour (h)
Standard Deviation 3.391
|
23.08 hour (h)
Standard Deviation 1.740
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The %AUCex was determined on Day 1 (after the first dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)
|
6.594 percentage (%)
Standard Deviation 2.931
|
5.672 percentage (%)
Standard Deviation 1.077
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Area under the concentration-time curve extrapolated to infinity, calculated, if feasible, as AUC0-t + Ct/Kel, where Ct is the last measurable drug concentration. The AUC(0-inf) was determined on day 1 (after the first dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC(0-inf))
|
12380 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 2424
|
22030 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 3290
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Apparent volume of distribution associated with the terminal slope, calculated, if feasible, as Dose/(AUC0-∞\*Kel). The Vd/F was determined on Day 1 (after the first dose) of safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vd/F)
|
142700 milliliter (mL)
Standard Deviation 33040
|
154800 milliliter (mL)
Standard Deviation 29600
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Apparent total body clearance, calculated, if feasible, as Dose/AUC0-∞. The CL/F was determined on Day 1 (after the first dose) of safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Apparent Clearance Following Oral Administration (CL/F)
|
4159 milliliter/ hour (mL/h)
Standard Deviation 697.2
|
4634 milliliter/ hour (mL/h)
Standard Deviation 707.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Mean residence time, calculated, if feasible, as AUMC0-∞/AUC0-∞, where AUMC0-∞ is area under the moment concentration-time curve extrapolated to infinity. The MRT was determined on Day 1 (after the first dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
34.65 hour (h)
Standard Deviation 5.324
|
33.12 hour (h)
Standard Deviation 1.988
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The AUMC was determined on Day 1 (after the first dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Area Under the First Moment of the Concentration-time Curve (AUMC)
|
431100 hour2* nanogram/milliliter (h2*ng/mL)
Standard Deviation 131600
|
729400 hour2* nanogram/milliliter (h2*ng/mL)
Standard Deviation 117100
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The Cmax\_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Maximum Safinamide Plasma Concentration at Steady State (Cmax_ss)
|
782.8 nnaogram/milliliter (ng/mL)
Standard Deviation 174.4
|
1501 nnaogram/milliliter (ng/mL)
Standard Deviation 249.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The tmax\_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Time Corresponding to Occurrence of Cmax_ss at Steady State (tmax_ss)
|
2.017 hour (h)
Interval 1.0 to 6.0
|
1.483 hour (h)
Interval 0.5 to 4.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The Cmin\_ss was determined on day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Minimum Observed Concentration at Steady State (Cmin_ss)
|
358.3 nanogram/liter (ng/mL)
Standard Deviation 107.8
|
583.2 nanogram/liter (ng/mL)
Standard Deviation 117.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The AUC0-t\_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve at Steady State From the Last Dose Administration to the Last Observed Concentration Time t (AUC0-t_ss)
|
24170 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 6349
|
42420 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 6676
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The AUC0-τ\_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
AUC Over the Dosing Interval at Steady State (AUC0-τ_ss)
|
13150 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 2781
|
23100 hour*nanogram/milliliter (h*ng/mL)
Standard Deviation 3541
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Average safinamide plasma concentration at steady state, calculated as AUC0- 24h\_ss /tau (24 h). The Cave\_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Average Safinamide Plasma Concentration at Steady State(Cave_ss)
|
548.0 nanogram/milliliter (ng/mL)
Standard Deviation 115.9
|
962.4 nanogram/milliliter (ng/mL)
Standard Deviation 147.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Racc,AUC was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Accumulation Ratio, Based on AUC (Racc,AUC)
|
2.101 ratio
Standard Deviation 0.2525
|
2.027 ratio
Standard Deviation 0.1367
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Racc,Cmax was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Accumulation Ratio, Based on Cmax (Racc,Cmax)
|
1.939 ratio
Standard Deviation 0.3691
|
1.898 ratio
Standard Deviation 0.1594
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Peak-trough fluctuation over one dosing interval at steady-state, calculated as (Cmax,ss - Cmin,ss)/Cave,ss\*100. The DF% was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Peak-trough Fluctuation Over One Dosing Interval at Steady-state (DF%)
|
77.75 percentage (%)
Standard Deviation 13.42
|
95.17 percentage (%)
Standard Deviation 11.90
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
Apparent volume of distribution at steady-state associated with the terminal slope, calculated, if feasible, as Dose/( AUC0-24h\_ss\*Kel). The Vd/F\_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Apparent Volume of Distribution at Steady-state Associated With the Terminal Slope (Vd/F_ss)
|
134400 milliliter (mL)
Standard Deviation 28640
|
153100 milliliter (mL)
Standard Deviation 30250
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All randomised subjects who fulfilled the study protocol requirements in terms of IMP intake and had evaluable PK data readouts, with no major deviations that might affect the PK results. This analysis set was used for the statistical analysis of the PK summaries and analyses.
The CL/F\_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=11 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Apparent Total Body Clearance at Steady-state, (CL/F_ss)
|
3933 milliliter/hour (mL/h)
Standard Deviation 705.8
|
4426 milliliter/hour (mL/h)
Standard Deviation 692.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to18Population: All randomised subjects who receive at least one dose of the investigational medicinal product(s). This analysis set will be used for the safety analyses.
Safety and general tolerability were assessed for safinamide.
Outcome measures
| Measure |
Cohort 1 (Safinamide 50mg)
n=12 Participants
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 2 (Safinamide 100mg)
n=12 Participants
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1) and later subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2). The single-dose in Period 1 and the first dose in Period 2 were separated by a washout interval of 7 days.
|
Cohort 1 (Safinamide 50mg) Multiple Dose
n=12 Participants
The received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
n=12 Participants
The received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
TEAE Related to IMP
|
6 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
Adverse Events
Cohort 1 (Safinamide 50mg) Single Dose
Cohort 2 (Safinamide 100mg) Single Dose
Cohort 1 (Safinamide 50mg) Multiple Dose
Cohort 2 (Safinamide 100mg) Multiple Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Safinamide 50mg) Single Dose
n=12 participants at risk
The subjects received 50mg single-dose of safinamide on Day 1 orally (Period 1).
|
Cohort 2 (Safinamide 100mg) Single Dose
n=12 participants at risk
The subjects received 100mg single-dose of safinamide on Day 1 orally (Period 1).
|
Cohort 1 (Safinamide 50mg) Multiple Dose
n=12 participants at risk
The subjects received 50mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
Cohort 2 (Safinamide 100mg) Multiple Dose
n=12 participants at risk
The subjects received 100mg one tablet once daily orally from Days 8 to 14 (Period 2).
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
25.0%
3/12 • Number of events 3 • From Screening to final visit/ Early termination visit (Day 18)
|
41.7%
5/12 • Number of events 5 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
16.7%
2/12 • Number of events 2 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 2 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Investigations
Blood uric acid increased
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
8.3%
1/12 • Number of events 1 • From Screening to final visit/ Early termination visit (Day 18)
|
0.00%
0/12 • From Screening to final visit/ Early termination visit (Day 18)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains confidential information of Zambon S.p.A., Italy. Do not copy or distribute without written permission from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER