drugset / Trial / NCT01674036
Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men
RandomizedParallel-groupDouble-blindTreatment
Summary
The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts. Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study; Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions. Subjects are not allowed to participate in more than 1 part of the study.
Timeline
- Start
- 2012-08
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venglustat | Small molecule | 2 mg | Oral |
| Subject | Venglustat | Small molecule | 5 mg | Oral |
| Subject | Venglustat | Small molecule | 15 mg | Oral |
| Subject | Venglustat | Small molecule | 25 mg | Oral |
| Subject | Venglustat | Small molecule | 50 mg | Oral |
| Subject | Venglustat | Small molecule | 100 mg | Oral |
| Subject | Venglustat | Small molecule | 150 mg | Oral |
Indications
No indication recorded.