Interventional, randomised, partial double-blind, placebo- and positive controlled, multiple-dose, 4-way-cross-over trial Investigating the effect of arimoclomol on cardiac repolarization in healthy men.
- Conditions
- protein aggregation and protein misfolding diseases (lysosomal storage diseases and neuromuscular disorders such as ALS
- Registration Number
- NL-OMON49378
- Lead Sponsor
- Orphazyme A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. The subject is able to read and understand the Subject Information Sheet and
Informed Consent Form.
2. The subject has signed the trial-specific Informed Consent Form.
3. The subject is a man
4. The subject must:
a. remain sexually abstinent, when this is in line with his preferred and usual
lifestyle OR
b. engage exclusively in same-sex relationships OR
c. agree to avoid impregnating his partner from the Screening Visit until 2
weeks after the last dose of IMP, AND
d. agree to use highly effective contraception methods as described in Appendix
4 from the Screening Visit until 2 weeks after dosing if his female partner is
of childbearing potential
e. not donate sperm until *3 months after the last dose of IMP
1. The subject has taken any prescription or non-prescription medication <1
week prior to the first IMP dosing or *5 half-lives prior to the Screening
Visit for any medication taken.
2. The subject has significant alcohol consumption, defined as an alcohol
intake >21 units per week, or substance use (excluding nicotine or caffeine)
deemed significant by the investigator, or a history of substance abuse (DSM-5®
criteria) <12 months prior to the Screening Visit. A unit of alcohol is defined
as 250 mL of lager/beer, 100 mL of wine, or 25 mL of spirits
3. The subject has taken any investigational medicinal product within 3 months
prior to the first IMP dosing.
4. The subject has taken any nutritional or dietary supplements, herbal
preparations, or vitamins within 7 days prior to the first IMP dosing.
5. The subject has previously been dosed with arimoclomol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method