Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898101
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2021-05-21
Brief Title:
A Study to Evaluate the Effect of 14CAcp-196 Acalabrutinib in Healthy Adult Participants
Sponsor:
Acerta Pharma BV
Organization:
Acerta Pharma BV
Study Overview
Official Title:
Absolute Bioavailability Pharmacokinetics Excretion and Metabolism of 14CAcp-196 Acalabrutinib in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-05
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 study is to determine the absolute bioavailability of oral acalabrutinib and intravenous IV PK of 14CACP-196
Detailed Description:
This is 2-cohort study Screening period will be within 28 days before the dose In the treatment period participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib and at 58 minutes postdose of acalabrutinib will receive a single microtracer 10 μg 1 μCi 14CACP-196 as a 5 mL IV push over 2 minutes and participants in Cohort 2 will receive a single 100 mL oral solution of acalabrutinib 1 mgmL oral solution containing a microtracer dose 10 μg 1 μCi of 14CACP-196 Cohort 1 participants will be confined continuously from Check-in until Day 5 and Cohort 2 participants will be confined continuously from Check-in until Day 8
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