Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects
- Conditions
- Metabolic disorder - Lysosomal storage diseaseFabry diseaseLysosomal storage disease
- Registration Number
- NL-OMON48323
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Part A only
1. Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.;Part B only
2. Healthy male and female subjects aged between 18 and 55 years (inclusive) at Screening.;Part A and B
3. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
4. Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration.;Further inclusion criteria can be found in the protocol section 3.2.2
Part B only
1. Known hypersensitivity to moxifloxacin or any of its excipients. ;Part A and B
2. Previous exposure to lucerastat.
3. Known hypersensitivity to any of lucerastat*s excipients.
4. Known hypersensitivity or allergy to natural rubber latex.;Further exclusion criteria can be found in the protocol section 3.2.3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>cardiodynamic variables</p><br>
- Secondary Outcome Measures
Name Time Method <p> Pharmacokinetic, safety and tolerability endpoints</p><br>