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The purpose of the study is to evaluate the plasma pharmacokinetic of padsevonil in adult and elderly study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult study participants | Experimental | Participants will receive assigned single and multiple doses of padsevonil. |
|
| Elderly study participants | Experimental | Participants will receive assigned single and multiple doses of padsevonil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Padsevonil | Drug | Padsevonil will be administered in predefined dosages. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil (PSL) | Cmax was measured in nanograms per milliliter (ng/mL). | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
| The Area Under the Curve From 0 to t (AUC0-t) of a Single Dose Padsevonil (PSL) | AUC0-t: area under the plasma concentration-time curve from time 0 to the last quantifiable concentration. It was measured in hours times nanograms per milliliter (h*ng/mL). | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
| The Area Under the Curve (AUC) of a Single Dose Padsevonil (PSL) | AUC was measured in hours times nanograms per milliliter (h*ng/mL). | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
| The Maximum Plasma Concentration at Steady-state (Cmax, ss) of Multiple Doses Padsevonil (PSL) | Cmax, ss was measured in nanograms per milliliter (ng/mL). | Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13 |
| The Area Under the Curve (AUCtau) Over a Dosing Interval of Multiple Doses Padsevonil (PSL) | AUCtau was measured in hours times nanograms per milliliter (h*ng/mL). | Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| The Amount of Padsevonil (PSL) Excreted in Urine | Samples were taken to assess the amount of padsevonil that was excreted in urine. Ae,ss refers to cumulative amount of PSL excreted in the urine at steady state. | Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13 |
| The Ratio of Padsevonil (PSL) to Its Metabolites Excreted in Urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0053 001 | San Antonio | Texas | 78209 | United States |
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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The study included a 28 days Screening period, a 21 days Treatment period: Period 1A single dose (SD) on Days 1 to 7 and Period 1B multiple dose (MD) on Days 8 to 21 and a Safety Follow-up period on Day 22.
Participant Flow refers to the Full Analysis Set.
The study started to enroll patients in July 2019 and concluded in October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults (18-64 Years) | Participants received assigned single and multiple doses of padsevonil. |
| FG001 | Elderly (>= 65 Years) | Participants received assigned single and multiple doses of padsevonil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline Characteristics refer to Full Analysis Set (FAS) which consisted of all study participants who signed the informed consent form (ICF) and received at least 1 dose of PSL.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults (18-64 Years) | Participants received assigned single and multiple doses of padsevonil. |
| BG001 | Elderly (>= 65 Years) | Participants received assigned single and multiple doses of padsevonil. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil (PSL) | Cmax was measured in nanograms per milliliter (ng/mL). | The Pharmacokinetic-Per Protocol Set (PK-PPS) was a subset of the FAS, consisting of study participants who had no important protocol deviation (IPD) affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
|
Treatment emergent adverse events were collected from Baseline until End-of-Treatment visit (up to Day 22)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults (18-64 Years) (FAS) SD Period (1A) | Participants received a single dose of padsevonil during Period (1A), forming the FAS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | clinicaltrials@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2019 | Apr 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2019 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708857 | padsevonil |
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Samples were taken to assess the metabolic ratio of padsevonil that was excreted in urine. MRAe was defined as the metabolic ratio of PSL to its metabolites for cumulative amount of PSL metabolites excreted in the urine. ss refers to steady state. |
| Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13 |
| Number of Participants With Treatment-emergent Adverse Events | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | From Baseline until End-of-Treatment visit (up to Day 22) |
| Number of Participants With Serious Adverse Events | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| From Baseline until End-of-Treatment visit (up to Day 22) |
| Number of Participants With Treatment-emergent Adverse Events Leading to Discontinuation of the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From Baseline until End-of-Treatment visit (up to Day 22) |
| BG002 | Total Title |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Elderly (>= 65 Years) (PK-PPS) |
Participants received assigned single and multiple doses of padsevonil, forming the PK-PPS. |
|
|
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| Primary | The Area Under the Curve From 0 to t (AUC0-t) of a Single Dose Padsevonil (PSL) | AUC0-t: area under the plasma concentration-time curve from time 0 to the last quantifiable concentration. It was measured in hours times nanograms per milliliter (h*ng/mL). | The Pharmacokinetic-Per Protocol Set (PK-PPS) was a subset of the FAS, consisting of study participants who had no important protocol deviation (IPD) affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
|
|
|
|
| Primary | The Area Under the Curve (AUC) of a Single Dose Padsevonil (PSL) | AUC was measured in hours times nanograms per milliliter (h*ng/mL). | The Pharmacokinetic-Per Protocol Set (PK-PPS) was a subset of the FAS, consisting of study participants who had no important protocol deviation (IPD) affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose |
|
|
|
|
| Primary | The Maximum Plasma Concentration at Steady-state (Cmax, ss) of Multiple Doses Padsevonil (PSL) | Cmax, ss was measured in nanograms per milliliter (ng/mL). | The PK-PPS was a subset of the FAS, consisting of study participants who had no IPD affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. 1 participant in the adult cohort discontinued due to a treatment emergent adverse event (TEAE) after 5 days of PSL administration in the MD Period. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13 |
|
|
|
|
| Primary | The Area Under the Curve (AUCtau) Over a Dosing Interval of Multiple Doses Padsevonil (PSL) | AUCtau was measured in hours times nanograms per milliliter (h*ng/mL). | The PK-PPS was a subset of the FAS, consisting of study participants who had no IPD affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. 1 participant in the adult cohort discontinued due to a TEAE after 5 days of PSL administration in the MD Period. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13 |
|
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|
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| Secondary | The Amount of Padsevonil (PSL) Excreted in Urine | Samples were taken to assess the amount of padsevonil that was excreted in urine. Ae,ss refers to cumulative amount of PSL excreted in the urine at steady state. | The Pharmacokinetic-Per Protocol Set (PK-PPS) was a subset of the FAS, consisting of study participants who had no important protocol deviation (IPD) affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams | Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13 |
|
|
|
| Secondary | The Ratio of Padsevonil (PSL) to Its Metabolites Excreted in Urine | Samples were taken to assess the metabolic ratio of padsevonil that was excreted in urine. MRAe was defined as the metabolic ratio of PSL to its metabolites for cumulative amount of PSL metabolites excreted in the urine. ss refers to steady state. | The Pharmacokinetic-Per Protocol Set (PK-PPS) was a subset of the FAS, consisting of study participants who had no important protocol deviation (IPD) affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13 |
|
|
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| Secondary | Number of Participants With Treatment-emergent Adverse Events | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. | The Full Analysis Set (FAS) consisted of all study participants who signed the informed consent form (ICF) and received at least 1 dose of PSL. | Posted | Count of Participants | Participants | From Baseline until End-of-Treatment visit (up to Day 22) |
|
|
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| Secondary | Number of Participants With Serious Adverse Events | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| The Full Analysis Set (FAS) consisted of all study participants who signed the informed consent form (ICF) and received at least 1 dose of PSL. | Posted | Count of Participants | Participants | From Baseline until End-of-Treatment visit (up to Day 22) |
|
|
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| Secondary | Number of Participants With Treatment-emergent Adverse Events Leading to Discontinuation of the Study | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Full Analysis Set (FAS) consisted of all study participants who signed the informed consent form (ICF) and received at least 1 dose of PSL. | Posted | Count of Participants | Participants | From Baseline until End-of-Treatment visit (up to Day 22) |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | Elderly (>= 65 Years) (FAS) SD Period (1A) | Participants received a single dose of padsevonil during Period (1A), forming the FAS. | 0 | 18 | 0 | 18 | 18 | 18 |
| EG002 | Adults (18-64 Years) (FAS) MD Period (1B) | Participants received multiple doses of padsevonil during Period (1B), forming the FAS. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG003 | Elderly (>= 65 Years) (FAS) MD Period (1B) | Participants received multiple doses of padsevonil during Period (1B), forming the FAS. | 0 | 18 | 0 | 18 | 17 | 18 |
| Vertigo | Ear and labyrinth disorders | MedDRA22.1 | Non-systematic Assessment |
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| Diplopia | Eye disorders | MedDRA22.1 | Non-systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA22.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA22.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Blood pressure systolic decreased | Investigations | MedDRA22.1 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA22.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA22.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Disinhibition | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Enuresis | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Mania | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
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| Multiple dose: Day 13 (Ae,ss) |
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| Metabolite 1, Single dose: Day 1 (Ae) |
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| Metabolite 1, Multiple dose: Day 13 (Ae,ss) |
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| Metabolite 2, Single dose: Day 1 (Ae) |
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| Metabolite 2, Multiple dose: Day 13 (Ae,ss) |
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| Metabolite 1, Multiple dose: Day 13 (MRAe,ss) |
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| Metabolite 2, Single dose: Day 1 (MRAe) |
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| Metabolite 2, Multiple dose: Day 13 (MRAe,ss) |
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