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

NCT01710826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-03-19

No results posted yet for this study

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

BIOLOGICAL

Genz-682452

Capsules for oral administration.

BIOLOGICAL

Placebo

Placebo capsules matching the Genz-682452 capsules.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710826 on ClinicalTrials.gov