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
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 |