Interventional, open-label, single-group, multiple-dose study investigating the pharmacokinetic properties of arimoclomol (BRX-345) and its metabolites following oral administration to healthy young me
Completed
- Conditions
- diseases regarding conditions that involve misfolded proteins or protein aggregation disordersALSGaucher's disease
- Registration Number
- NL-OMON45787
- Lead Sponsor
- Orphazyme A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters of arimoclomol including Cmax, tmax, AUC0-t, AUC0-8,<br /><br>AUC0-inf, CL/F, Vz/F, and t*, Cavg, AR, Ae, fe and CLR after multiple dose<br /><br>administration in healthy young male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety parameters include: adverse events (AEs), clinical laboratory<br /><br>assessments, vital signs, weight, ECG, physical and neurological examination<br /><br>and C-SSRS scores after multiple dose administration in healthy young male<br /><br>subjects.</p><br>