Neurodegenerative disorder PSP Steele-Richardson-Olszweski syndrome
Conditions
Interventions
ASN120290
Sponsors
Asceneuron SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Deemed healthy on the basis of medical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results and (c) is not evaluated as clinically significant.;Subjects must be between 18 and 75 years of age, inclusive, at Screening.;Male healthy volunteer, or women of non*childbearing potential (i.e. postmenopausal [the last spontaneous menstrual period was at least 12 months ago, and FSH at Screening confirms post*menopausal status (FSH *30 U/L)], or has no uterus, ovaries or fallopian tubes or has their fallopian tubes tied).;For more inclusion criteria please refer to the protocol.
Exclusion criteria
Exclusion criteria: Women who are pregnant, or lactating, or of child-bearing potential.;History of epilepsy or seizures, other than benign febrile convulsions in childhood.;Positive result for suicidal ideation or behavior using the C*SSRS at Screening.;For more exclusion criteria please refer to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints The pharmacokinetic parameter AUC0-inf will be used to evaluate the relative bioavailability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints * Safety and tolerability parameters including adverse events (AEs), physical examination, clinical laboratory values, vital signs, and ECG after single dose administration of the capsule under fasted condition and the film-coated tablet under fasted and fed conditions. * Pharmacokinetic parameters of ASN120290 and ASN120460 in plasma after single dose administration of the capsule under fasted condition and the film-coated tablet under fasted and fed conditions. | — |
Countries
Netherlands
Outcome results
None listed