diseases regarding conditions that involve misfolded proteins or protein aggregation disorders ALS Gaucher's disease
Conditions
Interventions
All subjects will receive multiple doses of 400 mg arimoclomol three times a
day (TID) for 5 consecutive days and a single morning dose on Day 6.
Sponsors
Orphazyme A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: subject is a man subject is older than or 18 and younger than or 45 years of age at Screening For more inclusion criteria, please refer to the protocol
Exclusion criteria
Exclusion criteria: The subject has a history of severe drug allergy or hypersensitivity. The subject has taken any investigational medicinal product within 3 months prior to the first dose of IMP. For more exclusion criteria, please refer to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of arimoclomol including Cmax, tmax, AUC0-t, AUC0-8, AUC0-inf, CL/F, Vz/F, and t*, Cavg, AR, Ae, fe and CLR after multiple dose administration in healthy young male subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters include: adverse events (AEs), clinical laboratory assessments, vital signs, weight, ECG, physical and neurological examination and C-SSRS scores after multiple dose administration in healthy young male subjects. | — |
Countries
Netherlands
Outcome results
None listed