NCT01710826

A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers

A Single-center, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending 14-day Repeated Oral Doses of Genz-682452 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess in healthy adult subjects: * The tolerability and safety of ascending repeated oral doses of Genz-682452. * The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses. * The pharmacodynamics of Genz-682452 after ascending repeated oral doses.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Genz-682452	Capsules for oral administration.
BIOLOGICAL	Placebo	Placebo capsules matching the Genz-682452 capsules.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-10-19
• Last updated: 2014-03-19

Locations

1 site across 1 country: United States