Healthy Japanese ParticipantsPhase 1NCT04075409

A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants

A Phase 1 study testing Padsevonil in people with Healthy Japanese Participants, run by UCB Biopharma S.P.R.L. at 1 site in Japan.

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

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants. Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Japanese Participants
What is being tested?: Padsevonil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteJapan
Study dates: 30 Sep 2019to 27 Dec 2019
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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
The study participant has a body weight ≥50 kg and body mass index within the range [18 to 30] kg/m^2 (inclusive)
The study participant is male

Who cannot join

The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)
The study participant has bilirubin >1.0 x ULN (isolated bilirubin >1.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %)

Show all 9Show fewer

The study participant has current or chronic history of liver disease or known hepatic or biliary abnormalities
The study participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline.
The study participant has made a blood or plasma donation or has had a comparable blood loss (>450 mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted

Trial locations and contacts

1 site in 1 country.

Japan1 site

Up0083 001
Tokyo

Other trials in Japan

About this study

Official title: An Open-Label, Parallel Group, Single-Center Study to Investigate the Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in CYP2C19 Genotyped Healthy Male Japanese Study Participants

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.

Conditions: Healthy Japanese Participants
Being tested: Padsevonil
Keywords: Padsevonil, CYP2C19, Healthy Japanese Participants, Pharmacokinetics

What participants receive

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

PadsevonilDrug
Padsevonil will be administered in predefined dosages.

Study groups in NCT04075409
Study group	Role	What they receive
Extensive metabolizers	Experimental	Participants will receive assigned single and multiple doses of padsevonil. Receives: Drug: Padsevonil
Intermediate metabolizers	Experimental	Participants will receive assigned single and multiple doses of padsevonil. Receives: Drug: Padsevonil
Poor metabolizers	Experimental	Participants will receive assigned single and multiple doses of padsevonil. Receives: Drug: Padsevonil

What is being measured

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

Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
AUC is the area under the plasma concentration-time curve from time zero to infinity.
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Terminal Half-life (t1/2) of a Single Dose Padsevonil
The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
The tmax is the time to reach maximum plasma concentration.
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.
Measured: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
AUCtau is the area under the plasma concentration time curve over a dosing interval.
Measured: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
Terminal Half-life (t1/2) of Multiple Doses Padsevonil
The t1/2 is the apparent terminal half-life.
Measured: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
The tmax, ss is the time of observed maximum plasma concentration at a steady-state.
Measured: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
Percentage of Participants With Treatment Emergent Adverse Events During the Study
An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Measured: From Baseline until the Safety Follow-up Visit (up to Day 21)

Timeline

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

30 Sep 201927 Dec 2019

First posted30 Aug 2019
Study start30 Sep 2019
Primary completion27 Dec 2019
Study completion27 Dec 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy Japanese ParticipantsStudies 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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04075409
Sponsor's protocol ID: UP0083
Other IDs: JapicCTI-194958
Status last verified: Jun 2021
First submitted: 29 Aug 2019
Last updated: 8 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Publications

Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.
PubMed 38932723

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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Parallel Group, Single-Center Study to Investigate the Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in CYP2C19 Genotyped Healthy Male Japanese Study Participants
ClinicalTrials.gov ID: NCT04075409
Acronym / sponsor ID: UP0083
Conditions: Healthy Japanese Participants
Keywords: Padsevonil, CYP2C19, Healthy Japanese Participants, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
Study start: 30 Sep 2019 (actual)
Primary completion: 27 Dec 2019 (actual)
Study completion: 27 Dec 2019 (actual)
First posted: 30 Aug 2019 (actual)
Results: Posted 8 Jul 2021

Clinical summary

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

The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Extensive metabolizers	Experimental	Drug: PadsevonilParticipants will receive assigned single and multiple doses of padsevonil.
Intermediate metabolizers	Experimental	Drug: PadsevonilParticipants will receive assigned single and multiple doses of padsevonil.
Poor metabolizers	Experimental	Drug: PadsevonilParticipants will receive assigned single and multiple doses of padsevonil.

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent
The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage
The study participant has a body weight ≥50 kg and body mass index within the range [18 to 30] kg/m^2 (inclusive)
The study participant is male

Key exclusion criteria (9 listed)

The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit
The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome
The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0 x upper limit of normal (ULN)

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
PadsevonilPadsevonil will be administered in predefined dosages.	Drug	Extensive metabolizers, Intermediate metabolizers, Poor metabolizers

Primary outcome

Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
AUC is the area under the plasma concentration-time curve from time zero to infinity.
Terminal Half-life (t1/2) of a Single Dose Padsevonil
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
The tmax is the time to reach maximum plasma concentration.
Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.
Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
AUCtau is the area under the plasma concentration time curve over a dosing interval.
Terminal Half-life (t1/2) of Multiple Doses Padsevonil
Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
The t1/2 is the apparent terminal half-life.
Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
Time frame: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose
The tmax, ss is the time of observed maximum plasma concentration at a steady-state.
Percentage of Participants With Treatment Emergent Adverse Events During the Study
Time frame: From Baseline until the Safety Follow-up Visit (up to Day 21)
An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Results and safety

Results posted to the registry on 8 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extensive Metabolizers	13	13
Intermediate Metabolizers	13	13
Poor Metabolizers	13	13

Primary outcome: Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil

Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3). Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	Poor Metabolizers (PK-PPS) n = 13	Intermediate Metabolizers (PK-PPS) n = 13	Extensive Metabolizers (PK-PPS) n = 13
Value	1029 (832.5 to 1272)	833.6 (674.6 to 1030)	721.3 (583.6 to 891.4)

Poor Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 1.426 (90% CI 1.112 to 1.830), ANOVA
Poor Metabolizers (PK-PPS) vs Intermediate Metabolizers (PK-PPS): LS means ratio: 1.234 (90% CI 0.9619 to 1.584), ANOVA
Intermediate Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 1.156 (90% CI 0.9008 to 1.483), ANOVA

Population analysed: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.

Primary outcome: Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil

Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3). Least squares mean (95% Confidence Interval). Unit: h*ng/mL

Measure	Poor Metabolizers (PK-PPS) n = 13	Intermediate Metabolizers (PK-PPS) n = 13	Extensive Metabolizers (PK-PPS) n = 13
Value	5988 (4976 to 7206)	4645 (3860 to 5589)	2823 (2346 to 3397)

Poor Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 2.122 (90% CI 1.706 to 2.638), ANOVA
Poor Metabolizers (PK-PPS) vs Intermediate Metabolizers (PK-PPS): LS means ratio: 1.289 (90% CI 1.037 to 1.603), ANOVA
Intermediate Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 1.646 (90% CI 1.323 to 2.046), ANOVA

Primary outcome: Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil

Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3). Least squares mean (95% Confidence Interval). Unit: h*ng/mL

Measure	Poor Metabolizers (PK-PPS) n = 13	Intermediate Metabolizers (PK-PPS) n = 13	Extensive Metabolizers (PK-PPS) n = 13
Value	6024 (5009 to 7245)	4666 (3879 to 5611)	2837 (2359 to 3412)

Poor Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 2.124 (90% CI 1.709 to 2.639), ANOVA
Poor Metabolizers (PK-PPS) vs Intermediate Metabolizers (PK-PPS): LS means ratio: 1.291 (90% CI 1.039 to 1.604), ANOVA
Intermediate Metabolizers (PK-PPS) vs Extensive Metabolizers (PK-PPS): LS means ratio: 1.645 (90% CI 1.324 to 2.044), ANOVA

Primary outcome: Terminal Half-life (t1/2) of a Single Dose Padsevonil

Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3). Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	Extensive Metabolizers (PK-PPS) n = 13	Intermediate Metabolizers (PK-PPS) n = 13	Poor Metabolizers (PK-PPS) n = 13
Value	5.018 (22.2)	5.904 (21.3)	6.138 (24.1)

Adverse events

Time frame: Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extensive Metabolizers Single Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Intermediate Metabolizers Single Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Poor Metabolizers Single Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Extensive Metabolizers Multiple Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Intermediate Metabolizers Multiple Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Poor Metabolizers Multiple Dose (SS)	0 of 13 (0%)	13 of 13 (100%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38932723Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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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.

UCB Cares study director

001 844 599 2273 (UCB)

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 Padsevonil in people with Healthy Japanese Participants, run by UCB Biopharma S.P.R.L. at 1 site in Japan.

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 5 inclusion and 9 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 8 Jul 2021. 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 Japan. 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 8 Jul 2021). 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 Plasma Concentration (Cmax) of a Single Dose Padsevonil (time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)). The study lists 10 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 NCT04075409, which also lists 1 linked publication.

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 8 Jul 2021.