Neurodegenerative Disorders PSP Steele-Richardson-Olszewski syndrome
Conditions
Interventions
The study will start with a screening. At the screening a physical examination
will take place, a neurological examination and a few other standard medical
assessments will be performed (ECG, vital
tolerability
pharmacodynamics
pharmacokinetics
safety
Sponsors
QPS Netherlands B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Healthy as determined by the investigator, based on a medical evaluation including medical history physical examination, neurological 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, 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 otherwise exclusionary (see Exclusion Criteria). 2.Men, age 18-55 inclusive (part 1a) or men and postmenopausal or surgically sterile women age 55-80 inclusive (study parts 1b and 2) or men and surgically sterile women age 18-75 years inclusive or postmenopausal women age 55-75 years inclusive (part 3), will be enrolled. Postmenopausal women must have had >= 12 months of spontaneous amenorrhea (with follicle-stimulating hormone [FSH] >= 38 mIU/mL). All women must have a negative pregnancy test result before administration of test article. Surgically sterile women are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound
Exclusion criteria
Exclusion criteria: 1. A positive urine drug screen/alcohol breath test at screening or Day -1. 2. Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. 3. A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation. 4. Acute suicidality or history of suicidal behaviour. 5. Previous exposure to ASN120290.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8.1.1 Primary Endpoints Part 1a: Safety parameters include adverse events (AEs), vital signs, ECG, telemetry, VAS for headache and nausea, physical examination, and laboratory values after single dose administration in 6 different dose levels. Part 1b: Safety parameters include adverse events (AEs), vital signs, ECG, physical examination and laboratory values in elderly subjects following single dose administration under fasted and fed condition. Part 2: Safety parameters include adverse events (AEs), vital signs, ECG, physical examination, laboratory values and C-SSRS score in elderly subjects following multiple dose administration. Part 3: Inhibition O-GlcNAcase in blood PBMCs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.1.2 Secondary Endpoints Part 1a: The relative bioavailability of ASN120290 in plasma and urine of healthy subjects after single dose administration of 6 different dose levels. Inhibition of O-GlcNAcase in PBMCs of healthy subjects after single dose administration of ASN120290. Part 1b: The relative bioavailability of ASN120290 in plasma and urine of elderly subjects after single dose administration under fasted and fed condition. Inhibition of O-GlcNAcase in PBMCs of elderly subjects following single dose administration under fasted and fed condition. Part 2: The relative bioavailability of ASN120290 in elderly subjects after multiple dose administration over 10 days. Inhibition O-GlcNAcase in PBMCs. Part 3: Pharmacokinetic parameters of ASN120290 and ASN120460 in plasma of healthy subjects after single dose administration of 1000 mg ASN120290. Safety parameters include adverse events (AEs), vital signs, ECG, VAS for headache and nausea, physical examination, neurological examination, and laboratory values after single dose administration of 1000 mg ASN120290 | — |
Countries
The Netherlands
Outcome results
None listed