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

NCT06143904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

  • Gaucher's Disease Type I

Interventions

DRUG

Genz-112638

Pharmaceutical form:Solution-Route of administration:IV

DRUG

Genz-112638

Pharmaceutical form:Capsule-Route of administration:Oral

DRUG

[14C]-Genz-112638

Pharmaceutical form:Solution-Route of administration:Oral

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2009-06-03
Primary Completion
2009-07-05
Completion
2009-07-05
FDA Drug
Yes

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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 NCT06143904 on ClinicalTrials.gov