HealthyPhase 1NCT03887221

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

A Phase 1 study testing Safinamide 50 mg and Safinamide 100mg in people with Healthy, run by Zambon SpA at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase I, single center, single and multiple-dose, open-label, randomised, parallel-group, pharmacokinetics, safety and tolerability study. The subjects will be randomised into two study cohorts to receive single and multiple doses of 50 mg safinamide (cohort 1), or single and multiple doses of 100 mg… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Safinamide 50 mg and Safinamide 100mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 21 Jun 2021to 20 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Informed consent: signed written informed consent before inclusion in the study
Sex and Age: males and females, 18-45-year old inclusive
Ethnicity: Chinese
Weight: body weight ≥ 50 kg;
Body Mass Index: 19-26 kg/m2 inclusive
Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting/supine position

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Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
No nicotine addiction (smoker subjects only): ability to abstain for smoking for the duration of the clinical study
Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception during the study and two weeks post-dose:
Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
A male sexual partner who agrees to use a male condom with spermicide
A sterile sexual partner
Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.
For all women, pregnancy test result must be negative at screening and day -1.

Who cannot join

Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; positive result on HIV, hepatitis B (HBV) (except for vaccination), hepatitis C (HCV). Retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.
Medications: medications, including over the counter medications, herbal remedies and traditional Chinese remedies for 2 weeks before the start of the study. In particular statins and β-Hydroxy β-methylglutaryl-CoA (HMG-CoA)reductase inhibitors in the 2 weeks before the screening visit; medicinal products that are Breast Cancer Resistance Protein (BCRP) substrates; treatment with morphine or other similar opioids, whose concomitant use with Monoamine oxidase B (MAO-B) inhibitors is contraindicated, Selective serotonin reuptake inhibitors (SSRIs), Serotonin-norepinephrine reuptake inhibitors (SNRIs), tri- or tetracyclic antidepressant, tramadol, pethidine, dextromethorphan, Monoamino oxidase (MAO) inhibitors (e.g. selegiline), meperidine derivatives and antiepileptic drugs in the 4 weeks before the screening visit; treatment with any known enzyme inhibiting or inducing agent within 4 weeks preceding the screening visit. Hormonal contraceptives for women will be allowed

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Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study
Blood donation: blood donations or blood components transfusion for 3 months before this study
Abuse drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes or equivalent amount of tobacco per day within 3 months prior to day-1)
Abuse drug test: positive result at urine drug test at screening or day-1
Alcohol test: positive alcohol breath test at day -1
Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians; consumption of grapefruit or products containing grapefruit within 48 hours prior to the enrolment; consumption of beverages containing xanthines (e.g. coffee, tea, soda, coffee, milk, energy drinks) within 48 hours prior to the enrolment
Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital, Shanghai Jiao Tong University School of Med
Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Phase I, Pharmacokinetics, Safety and Tolerability Study of Single and Multiple Oral Doses of Safinamide in Healthy Adult Chinese Volunteers

Cohort 1: One safinamide 50 mg film-coated tablet will be administered on day 1 followed by 7 safinamide 50 mg film-coated tablets in total from day 8 to day 14 and hence administered 1 tablet orally from day 8 to day 14.

Cohort 2: One safinamide 100 mg film-coated tablet will be administered on day 1 followed by 7 safinamide 100 mg film-coated tablets in total from day 8 to day 14 and hence administered 1 tablet orally from day 8 to day 14.

The investigational products will be administered in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.

The primary endpoint will assess the pharmacokinetic parameters after single and multiple dose administration of the study drug. The secondary endpoint will provide the safety and tolerability data after single and multiple dose administration of the study drug.

Conditions: Healthy
Being tested: Safinamide 50 mg, Safinamide 100mg
Keywords: Pharmacokinetic, Safety, Tolerability, Healthy Chinese subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Safinamide 50 mgDrug
Safinamide 50mg film-coated tablets will be administered to subjects in Cohort 1. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.
Safinamide 100mgDrug
Safinamide 100mg film-coated tablets will be administered to subjects in Cohort 2. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.

Study groups in NCT03887221
Study group	Role	What they receive
Safinamide 50mg	Experimental	The subjects will receive 50mg safinamide on Day 1 of Period 1 and on Days 8 to 14 in period 2. Receives: Drug: Safinamide 50 mg
Safinamide 100mg	Experimental	The subjects will receive 100mg safinamide on Day 1 of Period 1 and on Days 8 to 14 in period 2. Receives: Drug: Safinamide 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Safinamide Plasma Concentration (Cmax)
The Cmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Measured: Day 1 and Day 8
Time Corresponding to Occurrence of Cmax (Tmax)
The tmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of Safinamide.
Measured: Day 1 and Day 8
Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t)
The (AUC0-t) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Measured: Day 1 and Day 8
Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h)
The (AUC0-24h) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of safinamide.
Measured: Day 1 and Day 8
Last Quantifiable Concentration (Clast/Ct)
The (Clast/Ct) was determined on Day 1 (after the first dose) of safinamide.
Measured: Day 1
Terminal Elimination Rate Constant (Kel)
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.
Measured: Day 1
Apparent Terminal Elimination Half Life (t1/2)
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.
Measured: Day 1
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)
The %AUCex was determined on Day 1 (after the first dose) of Safinamide.
Measured: Day 1
AUC From Time Zero Extrapolated to Infinity (AUC(0-inf))
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.
Measured: Day 1
Apparent Volume of Distribution During Terminal Phase (Vd/F)
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.
Measured: Day 1
Apparent Clearance Following Oral Administration (CL/F)
Apparent total body clearance, calculated, if feasible, as Dose/AUC0-∞. The CL/F was determined on Day 1 (after the first dose) of safinamide.
Measured: Day 1
Mean Residence Time (MRT)
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.
Measured: Day 1
Area Under the First Moment of the Concentration-time Curve (AUMC)
The AUMC was determined on Day 1 (after the first dose) of Safinamide.
Measured: Day 1
Maximum Safinamide Plasma Concentration at Steady State (Cmax_ss)
The Cmax_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Measured: Day 14
Time Corresponding to Occurrence of Cmax_ss at Steady State (tmax_ss)
The tmax_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Measured: Day 14
Minimum Observed Concentration at Steady State (Cmin_ss)
The Cmin_ss was determined on day 14 (after the multiple dose) of Safinamide.
Measured: Day 14
Area Under the Concentration-time Curve at Steady State From the Last Dose Administration to the Last Observed Concentration Time t (AUC0-t_ss)
The AUC0-t_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Measured: Day 14
AUC Over the Dosing Interval at Steady State (AUC0-τ_ss)
The AUC0-τ_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Measured: Day 14
Average Safinamide Plasma Concentration at Steady State(Cave_ss)
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.
Measured: Day 14
Accumulation Ratio, Based on AUC (Racc,AUC)
Racc,AUC was determined on Day 14 (after the multiple dose) of Safinamide.
Measured: Day 14
Accumulation Ratio, Based on Cmax (Racc,Cmax)
Racc,Cmax was determined on Day 14 (after the multiple dose) of Safinamide.
Measured: Day 14
Peak-trough Fluctuation Over One Dosing Interval at Steady-state (DF%)
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.
Measured: Day 14
Apparent Volume of Distribution at Steady-state Associated With the Terminal Slope (Vd/F_ss)
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.
Measured: Day 14
Apparent Total Body Clearance at Steady-state, (CL/F_ss)
The CL/F_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Measured: Day 14

Secondary outcomes (1)

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Safety and general tolerability were assessed for safinamide.
Measured: Day 1 to18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202120 Aug 2021

First posted22 Mar 2019
Study start21 Jun 2021
Primary completion20 Aug 2021
Study completion20 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: There will be 2 treatment groups. A total of 24 subjects will be randomized to receive 50mg or 100 mg Safinamide in Period 1 (Day 1) and Period 2 (Days 8 to 14) separated by a 7 days washout period.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03887221
Sponsor's protocol ID: Z7219J03
Status last verified: May 2022
First submitted: 18 Mar 2019
Last updated: 17 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Pending

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Pharmacokinetics, Safety and Tolerability Study of Single and Multiple Oral Doses of Safinamide in Healthy Adult Chinese Volunteers
ClinicalTrials.gov ID: NCT03887221
Acronym / sponsor ID: Z7219J03
Conditions: Healthy
Keywords: Pharmacokinetic, Safety, Tolerability, Healthy Chinese subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Zambon SpAIndustry (pharma, biotech, devices)
Study start: 21 Jun 2021 (actual)
Primary completion: 20 Aug 2021 (actual)
Study completion: 20 Aug 2021 (actual)
First posted: 22 Mar 2019 (actual)
Results: Posted 17 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: There will be 2 treatment groups. A total of 24 subjects will be randomized to receive 50mg or 100 mg Safinamide in Period 1 (Day 1) and Period 2 (Days 8 to 14) separated by a 7 days washout period.

Arm	Type	Receives
Safinamide 50mg	Experimental	Drug: Safinamide 50 mgThe subjects will receive 50mg safinamide on Day 1 of Period 1 and on Days 8 to 14 in period 2.
Safinamide 100mg	Experimental	Drug: Safinamide 100mgThe subjects will receive 100mg safinamide on Day 1 of Period 1 and on Days 8 to 14 in period 2.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Informed consent: signed written informed consent before inclusion in the study
Sex and Age: males and females, 18-45-year old inclusive
Ethnicity: Chinese
Weight: body weight ≥ 50 kg;
Body Mass Index: 19-26 kg/m2 inclusive

Key exclusion criteria (13 listed)

Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities
Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; positive result on HIV, hepatitis B (HBV) (except for vaccination), hepatitis C (HCV). Retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Safinamide 50 mgSafinamide 50mg film-coated tablets will be administered to subjects in Cohort 1. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.	Drug	Safinamide 50mg
Safinamide 100mgSafinamide 100mg film-coated tablets will be administered to subjects in Cohort 2. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.	Drug	Safinamide 100mg

Primary outcome

Maximum Safinamide Plasma Concentration (Cmax)
Time frame: Day 1 and Day 8
The Cmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Time Corresponding to Occurrence of Cmax (Tmax)
Time frame: Day 1 and Day 8
The tmax was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of Safinamide.
Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t)
Time frame: Day 1 and Day 8
The (AUC0-t) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple doses) of Safinamide.
Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h)
Time frame: Day 1 and Day 8
The (AUC0-24h) was determined on Day 1 (after the first dose), on Day 8 (after the first multiple dose) of safinamide.
Last Quantifiable Concentration (Clast/Ct)
Time frame: Day 1
The (Clast/Ct) was determined on Day 1 (after the first dose) of safinamide.
Terminal Elimination Rate Constant (Kel)
Time frame: Day 1
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.
Apparent Terminal Elimination Half Life (t1/2)
Time frame: Day 1
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.
Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex)
Time frame: Day 1
The %AUCex was determined on Day 1 (after the first dose) of Safinamide.
AUC From Time Zero Extrapolated to Infinity (AUC(0-inf))
Time frame: Day 1
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.
Apparent Volume of Distribution During Terminal Phase (Vd/F)
Time frame: Day 1
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.
Apparent Clearance Following Oral Administration (CL/F)
Time frame: Day 1
Apparent total body clearance, calculated, if feasible, as Dose/AUC0-∞. The CL/F was determined on Day 1 (after the first dose) of safinamide.
Mean Residence Time (MRT)
Time frame: Day 1
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.
Area Under the First Moment of the Concentration-time Curve (AUMC)
Time frame: Day 1
The AUMC was determined on Day 1 (after the first dose) of Safinamide.
Maximum Safinamide Plasma Concentration at Steady State (Cmax_ss)
Time frame: Day 14
The Cmax_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Time Corresponding to Occurrence of Cmax_ss at Steady State (tmax_ss)
Time frame: Day 14
The tmax_ss was determined on day 14 (after the multiple-dose) of Safinamide.
Minimum Observed Concentration at Steady State (Cmin_ss)
Time frame: Day 14
The Cmin_ss was determined on day 14 (after the multiple dose) of Safinamide.
Area Under the Concentration-time Curve at Steady State From the Last Dose Administration to the Last Observed Concentration Time t (AUC0-t_ss)
Time frame: Day 14
The AUC0-t_ss was determined on Day 14 (after the multiple dose) of Safinamide.
AUC Over the Dosing Interval at Steady State (AUC0-τ_ss)
Time frame: Day 14
The AUC0-τ_ss was determined on Day 14 (after the multiple dose) of Safinamide.
Average Safinamide Plasma Concentration at Steady State(Cave_ss)
Time frame: Day 14
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.
Accumulation Ratio, Based on AUC (Racc,AUC)
Time frame: Day 14
Racc,AUC was determined on Day 14 (after the multiple dose) of Safinamide.
Accumulation Ratio, Based on Cmax (Racc,Cmax)
Time frame: Day 14
Racc,Cmax was determined on Day 14 (after the multiple dose) of Safinamide.
Peak-trough Fluctuation Over One Dosing Interval at Steady-state (DF%)
Time frame: Day 14
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.
Apparent Volume of Distribution at Steady-state Associated With the Terminal Slope (Vd/F_ss)
Time frame: Day 14
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.
Apparent Total Body Clearance at Steady-state, (CL/F_ss)
Time frame: Day 14
The CL/F_ss was determined on Day 14 (after the multiple dose) of Safinamide.

1 secondary outcome

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to18

Results and safety

Results posted to the registry on 17 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Safinamide 50mg)	12	11
Cohort 2 (Safinamide 100mg)	12	12

Primary outcome: Maximum Safinamide Plasma Concentration (Cmax)

Time frame: Day 1 and Day 8. Mean (Standard Deviation). Unit: nanogram/milliliter (ng/mL)

Measure	Cohort 1 (Safinamide 50mg) n = 11	Cohort 2 (Safinamide 100mg) n = 12
Day 1	411.5 (96.58)	792.1 (124.0)
Day 8	465.0 (86.94)	825.3 (183.5)

Population analysed: 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.

Primary outcome: Time Corresponding to Occurrence of Cmax (Tmax)

Time frame: Day 1 and Day 8. Median (Full Range). Unit: hour (h)

Measure	Cohort 1 (Safinamide 50mg) n = 11	Cohort 2 (Safinamide 100mg) n = 12
Day 1	1.500 (0.50 to 3.00)	1.750 (1.00 to 3.00)
Day 8	2.000 (0.50 to 8.00)	1.508 (1.00 to 3.00)

Population analysed: 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.

Primary outcome: Area Under the Concentration-time Curve From Single-dose Administration to the Last Quantifiable Concentration-time t (AUC0-t)

Time frame: Day 1 and Day 8. Mean (Standard Deviation). Unit: hour* nanogram/milliliter (h*ng/mL)

Measure	Cohort 1 (Safinamide 50mg) n = 11	Cohort 2 (Safinamide 100mg) n = 12
Day 1	11560 (2170)	20790 (3131)
Day 8	6652 (985.5)	12130 (1846)

Primary outcome: Area Under the Concentration-time Curve in the Tau Interval (From Single Dose Administration to 24 h Post Dose) (AUC0-24h)

Time frame: Day 1 and Day 8. Mean (Standard Deviation). Unit: hour*nanogram/milliliter (h*ng/mL)

Measure	Cohort 1 (Safinamide 50mg) n = 11	Cohort 2 (Safinamide 100mg) n = 12
Day 1	6291 (1158)	11420 (1727)
Day 8	6649 (986.3)	12090 (1931)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From Screening to final visit/ Early termination visit (Day 18). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (Safinamide 50mg) Single Dose	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Cohort 2 (Safinamide 100mg) Single Dose	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Cohort 1 (Safinamide 50mg) Multiple Dose	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Cohort 2 (Safinamide 100mg) Multiple Dose	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. Pending

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Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Safinamide 50 mg and Safinamide 100mg in people with Healthy, run by Zambon SpA at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Safinamide Plasma Concentration (Cmax) (time frame: Day 1 and Day 8). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.