Primary objectivePart A* To determine the supra-therapeutic dose of lucerastat to be used in Part B.Part B* To demonstrate that lucerastat does not have an effect on the QT interval corrected for heart rate (QTc) interval exceeding 10 ms using…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Metabolic disorder - Lysosomal storage disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
cardiodynamic variables
Secondary outcome
Pharmacokinetic, safety and tolerability endpoints
Background summary
Lucerastat is being developed for the treatment of Fabry disease, a rare
hereditary disorder. Fabry disease is a so-called lysosomal storage disorder.
Study objective
Primary objective
Part A
* To determine the supra-therapeutic dose of lucerastat to be used in Part B.
Part B
* To demonstrate that lucerastat does not have an effect on the QT interval
corrected for heart rate (QTc) interval exceeding 10 ms using concentration-QTc
analysis.
Study design
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
Intervention
Lucerastat, moxifloxacin or placebo
Study burden and risks
The risk to health at the chosen dose is limited, but the volunteers may
experience any of the side effects written in the ICF or symptoms that have not
been reported before.
Volunteers health is closely monitored during the study to minimize these
risks.
If the volunteers experience side effects, the investigator will treat them
where necessary. If new information is available on the safety of the study
medication, the volunteers are informed as soon as possible. The blood
collection procedure is not dangerous.
Hegenheimermattweg 91
Allschwil CH-4123
CH
Hegenheimermattweg 91
Allschwil CH-4123
CH
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004546-42-NL |
| CCMO | NL68517.056.18 |