A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants

Gaucher's Disease Type I Clinical Trial

Official title: An Open-Label Study to Evaluate the Absolute Bioavailability of Genz-112638 and the Absorption, Metabolism, and Excretion of [14C]-Genz-112638 in Male Subjects

Status Completed

Clinical Trial Summary

Objectives:

To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma, after a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled).

To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single dose of [14C]-Genz-112638.

Clinical Trial Description

The maximum study duration for an individual subject was approximately 65 days from the beginning of Screening through the Safety Follow-up visit. ;

Related Conditions & MeSH terms

• Gaucher Disease
• Gaucher's Disease Type I

• NCT number: NCT06143904
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2009
• Completion date: July 5, 2009