Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833049
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2021-04-05
Brief Title:
Study to Evaluate Absorption Metabolism and Excretion of TAK-994 in 6 Healthy Male Adults
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance Pharmacokinetics Absorption Metabolism and Excretion of 14CTAK-994 in Male Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-06
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:
The aim of this study is to understand how TAK-994 is processed by the body
This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994
This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994
Detailed Description:
The drug being tested in this study is called TAK-994 TAK-994 is being tested in healthy male participants This study will characterize how TAK -994 is absorbed metabolize excreted by the body after single oral administration by collecting plasma urine and feces samples for testing
The study will enroll approximately 6 participants The study consists of 2 parts Part A and Part B
In Part A all participants will receive TAK-994 as tablet and 14CTAK-994 as intravenous infusion In Part B all participants will receive a single dose of 14CTAK-994 as an oral suspension
This single-center trial will be conducted in the United States The overall time to participate in this study is approximately 67 days including a 28-day screening period plus approximately 30 days for follow up
The study will enroll approximately 6 participants The study consists of 2 parts Part A and Part B
In Part A all participants will receive TAK-994 as tablet and 14CTAK-994 as intravenous infusion In Part B all participants will receive a single dose of 14CTAK-994 as an oral suspension
This single-center trial will be conducted in the United States The overall time to participate in this study is approximately 67 days including a 28-day screening period plus approximately 30 days for follow up
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