Viewing Study NCT06143904



Ignite Creation Date: 2024-05-06 @ 7:48 PM
Last Modification Date: 2024-10-26 @ 3:14 PM
Study NCT ID: NCT06143904
Status: COMPLETED
Last Update Posted: 2023-11-22
First Post: 2023-11-16

Brief Title: A Study to Evaluate Absolute Bioavailability Absorption Metabolism and Excretion of Genz-112638 in Healthy Male Participants
Sponsor: Sanofi
Organization: Sanofi

Study Overview

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
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: The maximum study duration for an individual subject was approximately 65 days from the beginning of Screening through the Safety Follow-up visit

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U1111-1294-7994 REGISTRY ICTRP None