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

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 - CS0311 (ID-069-106)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48323

Enrollment

Registered

2019-01-08

Start date

2019-02-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic disorder - Lysosomal storage disease Fabry disease Lysosomal storage disease

Interventions

Lucerastat, moxifloxacin or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
cardiodynamic variables	—

Secondary

Measure	Time frame
Pharmacokinetic, safety and tolerability endpoints	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)