Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04147910
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2019-10-09
Brief Title:
Phase 1 Open-label Study of the Absorption Metabolism and Excretion of 14C-KW-6356
Sponsor:
Kyowa Kirin Inc
Organization:
Kyowa Kirin Co Ltd
Study Overview
Official Title:
A Phase 1 Open-label Study of the Absorption Metabolism and Excretion of 14C-KW-6356 Following a Single Oral Dose in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This is an open-label single-dose study in healthy male subjects to investigate the absorption metabolism and excretion AME of KW-6356
Detailed Description:
Subjects will be screened to assess their eligibility to enter the study within approximately 4 weeks prior to dose administration Subjects will be confined to the Clinical Research Unit CRU for their entire participation in this study Eight subjects will be enrolled to allow 6 subjects to complete the study Each subject will report to the CRU and be confined from Day -1 the day before dosing through at least Day 8 168 hours postdose A single dose of study drug will be administered on Day 1 0 hour On Day 8 subjects can be asked to remain as a resident within the CRU for an additional period to allow for ongoing 24-hour urine fecal and blood sample collections These collections can continue up to a maximum of 336 hours postdose Day 15 Subjects can be discharged prior to Day 15 if the following individual subject discharge criteria have been satisfied 90 of the 14C dose recovered in combined urine and feces and 1 of the total radioactive dose is recovered in combined excreta urine and feces in 3 consecutive 24-hour periods in which a fecal sample is provided
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