Epilepsy, Healthy Participants
Conditions
Keywords
Phase 1, Padsevonil, Bioavailability, Food effect
Brief summary
The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of PSL using a PSL reference tablet under fed and fasted conditions at 200 mg and 400 mg.
Interventions
DRUGPadsevonil type 1 Tablet 200 mg
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 1 tablet in a pre-specified sequence during the Treatment Period.
DRUGPadsevonil type 2 Tablet
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 2 tablet in a pre-specified sequence during the Treatment Period
DRUGPadsevonil type 3 Tablet
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 3 tablet in a pre-specified sequence during the Treatment Period.
DRUGPadsevonil type 4 Tablet
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 4 tablet in a pre-specified sequence during the Treatment Period.
DRUGPadsevonil type 5 Tablet
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Subjects will receive a padsevonil type 5 tablet in a pre-specified sequence during the Treatment Period.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
In Part 1 a single oral dose of padsevonil 200 mg for the 4 different product variants and the padsevonil reference tablet will be administered to all subjects in the fasted state in a randomized 5-way crossover design. In order to explore the food interaction with padsevonil, in Part 2 a single oral dose of a padsevonil reference tablet at dose levels of 200 mg and 400 mg (2x 200mg tablets) will be administered to all subjects in the fasted and fed state in a randomized 4-way crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent form (ICF) * Study participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Study participants must have a body weight of at least 50 kg for males and 45 kg for females and body mass index within the range 18 to 35 kg/m2 (inclusive) * Study participants who are male or female: 1. A male participant must agree to use contraception during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period 2. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days (or 5 terminal half-lives) after the last dose of study medication
Exclusion criteria
* 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 or a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of padsevonil type 1 tablets (200 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 1 tablets (400 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 1 tablets (200 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | Cmax: Maximum observed plasma concentration |
| AUC0-t of padsevonil type 1 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 2 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 3 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 4 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 5 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 1 tablets (2x200 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 1 tablets (2x200 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 1 tablets (200 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC0-t of padsevonil type 1 tablets (200 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC(0-t): Area under the plasma concentration-time curve from time zero to time t |
| AUC of padsevonil type 1 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 2 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 3 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 4 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 5 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 1 tablets (400 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 1 tablets (400 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 1 tablets (200 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC: Area under the concentration-time curve from time 0 to infinity |
| AUC of padsevonil type 1 tablets (200 mg, fed) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | AUC: Area under the concentration-time curve from time 0 to infinity |
| Cmax of padsevonil type 1 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 2 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 3 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 4 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 5 tablets during part 1 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 1. | Cmax: Maximum observed plasma concentration |
| Cmax of padsevonil type 1 tablets (400 mg, fasted) during part 2 | Plasma samples will be taken at: predose and 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 ,12, 24, 36, 48, 60, and 72 hours during part 2. | Cmax: Maximum observed plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) | From Baseline up to Day 35 | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | From Baseline up to Day 35 | An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. |
Outcome results
None listed