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

NCT ID: NCT06143904

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-03

Study Completion Date

2009-07-05

Brief Summary

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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.

Detailed Description

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

Conditions

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Gaucher's Disease Type I

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment Period 1 -2

Single-dose Intravenous (IV) Genz-112638 Day 1 followed by single dose GenZ-112638 oral capsules Day 8

Group Type EXPERIMENTAL

Genz-112638

Intervention Type DRUG

Pharmaceutical form:Solution-Route of administration:IV

Genz-112638

Intervention Type DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Treatment Period 1-4

Single-dose Intravenous (IV) Genz-112638 Day 1; single dose GenZ-112638 oral capsules Day 8; oral capsule Genz-112638 Days 9-14; single dose \[14C\]-Genz-112638 oral solution Day 15

Group Type EXPERIMENTAL

Genz-112638

Intervention Type DRUG

Pharmaceutical form:Solution-Route of administration:IV

Genz-112638

Intervention Type DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

[14C]-Genz-112638

Intervention Type DRUG

Pharmaceutical form:Solution-Route of administration:Oral

Interventions

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Genz-112638

Pharmaceutical form:Solution-Route of administration:IV

Intervention Type DRUG

Genz-112638

Pharmaceutical form:Capsule-Route of administration:Oral

Intervention Type DRUG

[14C]-Genz-112638

Pharmaceutical form:Solution-Route of administration:Oral

Intervention Type DRUG

Other Intervention Names

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GZ385660/ eliglustat Cerdelga GZ385660/ eliglustat GZ385660/ eliglustat

Eligibility Criteria

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Exclusion Criteria

Prolonged QTc interval (eg, repeated demonstration of a QTc interval ≥450 msec), family history of long QT or Brugada Syndrome, and/or history of sudden death in a first-degree relative.

The subject receives an immunization within 30 days of providing informed consent.

The subject has a history of drug allergies (eg, significant rash, hives, etc in response to antibiotics).

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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U1111-1294-7994

Identifier Type: REGISTRY

Identifier Source: secondary_id

GZGD02107

Identifier Type: -

Identifier Source: org_study_id