NCT01674036

Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of Genz-682452 With a Pilot Investigation of Food Effect in Healthy Adult Male Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Genz-682452	Capsules for oral administration.
DRUG	Placebo	Placebo to Genz-682452

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-08-28
• Last updated: 2014-03-19

Locations

1 site across 1 country: United States