epilepsy
Conditions
Interventions
Experimental group:Padsevonil(PSL) 200 mg
control group:placebo
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subject is informed and given ample time and opportunity to think about participation and has signed and dated the Independent Ethics Committee (IEC)-approved, written ICF. 2. Subjects are Chinese males and females born in China whose parents are of Chinese origin. 3. The subject is considered reliable and capable of adhering to the protocol and study procedures and is capable of communicating satisfactorily with the Investigator. 4. The subject is male or female between 18 and 45 years of age inclusive, at the time of signing the ICF. 5. The subject has a BW >= 50kg for males and >= 45kg for females and a BMI within the range 18.0 to 28.0 kg/m2 (inclusive). 6. The subject is healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the UCB Medical Monitor agree that the finding is unlikely to introduce additional risk factors or interfere with the study procedures. 7. Subject has BP and pulse rate within normal range in the supine position after 10 minutes rest (SBP: 90mmHg to 140mmHg, DBP: 60mmHg to 90mmHg, pulse rate: 40bpm to 100bpm). Any values marginally (ie, no more than 5mmHg) outside the normal range but considered not clinically significant by the Investigator would be allowed. Findings outside these permitted ranges may be retested up to 3 times – if the mean value of these retests is within range, then the subject may be included without reference to the Medical Monitor. 8. Female subjects use an efficient form of contraception for the duration of the study (unless menopausal [defined as no menses for 12 months without an alternative medical cause]; a high follicle-stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy). Hormonal contraception may be susceptible to an interaction with the IMP, which may reduce the efficacy of the contraception method. The potential for reduced efficacy of any hormonal contraception method requires that a barrier method (preferably male condom) also be used. To ensure proper birth control, females who use hormonal contraception should use an effective barrier contraceptive in the 3 months following the end of the study (ie, for 3 months after the last intake of study medication). 9. Male subject agrees that, during the study period and until 3 months after dosing, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive (condom) and that the respective partner will use an additional efficient contraceptive method (e.g., oral pills, intrauterine devices, or diaphragm, and spermicide).
Exclusion criteria
Exclusion criteria: 1. The subject has received an IMP (or a medical device) within the following time period prior to Day 1 in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the IMP or medical device (whichever is longer). 2. Subject has a known hypersensitivity to any components of the PSL formulation, or a history of drug or other allergy that, in the opinion of the Investigator or UCB Medical Monitor, contraindicates their participation. 3. History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, pancreatic, hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or dermatological disorders, or any type of cancer, with the exception of basal cell carcinoma. 4. Subject has alanine aminotransferase (ALT), alkaline phosphatase (ALP), or bilirubin that is above the upper limit of normal (ULN) or, in the case of Gilberts Syndrome, bilirubin that is >= 1.5 x ULN. If the subject only has >= 1.5 x ULN bilirubin (in the absence of elevated ALT or ASP), use fractionated bilirubin to identify possible undiagnosed Gilberts syndrome (ie, direct bilirubin ULN ALT, aspartate aminotransferase (AST), or ALP up to 25% above the exclusion limit at screening, tests may be repeated once for confirmation. This includes rescreening, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of values marginally outside the normal range, their clinical insignificance must be agreed between the Investigator and the Medical Monitor prior to inclusion of the subject. 5. The use of concomitant medications is prohibited as follows: Use of prescription medications within 14 days prior to dosing that in the judgment of the investigator could alter the parameters measured in the study or put the subject at risk. Use of over-the-counter or herbal medications within 2 weeks or 5 half-lives of the respective drug prior to dosing that in the judgment of the Investigator could alter the parameters measured in the study or put the subject at risk (eg, inducers or inhibitors of CYP3A4 and CYP2C19). In case of uncertainty, the Medical Monitor should beconsulted. 6. Subject ingests grapefruit, starfruit, and pawpaw (as beverage, fruit or supplements) within 72 hours before IMP administration. These fruits are not allowed during the treatment period and throughout the study. Subjects may be rescreened as needed. 7. Any history of significant bleeding or hemorrhagic tendencies. 8. The subject has a history of excessive alcohol consumption, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. One unit is equivalent to a half-pint (240mL) of beer or 1 measure (25mL) of spirits or 1 glass (125mL) of wine. 9. Subject has a consumption of more than 600mg of caffeine/day (200mL of coffee contains approximately 100mg of caffeine, 200mL of black tea approximately 30mg, and 200mL ofcola approximately 20mg). 10. Subject smokes more than 5 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit. 11. The subject has a positive urine test for substances of abuse. Subjects can be rescreened once at the discretion of the Investigator. A minimum list of drugs that will be screened for includes amphetamine, cocaine, opiates, cannabinoids and benzodiazepines. 12. Study subject has a history of or a current clinically significant ps
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety assessments; | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital, Sichuan University
Outcome results
None listed