Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879589
Status:
WITHDRAWN
Last Update Posted:
2023-04-28
First Post:
2021-04-26
Brief Title:
Phase 1 Study of ATRS-2002 in Healthy Male Adults
Sponsor:
Syneos Health
Organization:
Syneos Health
Study Overview
Official Title:
Phase 1 Open-Label Single-Ascending Dose Parallel Group Study to Determine the Pharmacokinetics Safety and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males
Status:
WITHDRAWN
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study abandoned no participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To access the safety tolerability pharmacokinetics and pharmacodynamics of subcutaneously administered ATRA-2002 against commercially available oral formulation of abiraterone acetate in healthy male adults
Detailed Description:
The study will be conducted in 4 dosing groups of 8 subjects each
Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous SC dose of ATRS-2002 abiraterone acetate or a single oral dose of the commercially available formulation of abiraterone acetate Zytiga Additionally for Cohorts 1 through 3 a single subject will be randomized as a sentinel subject to be dosed at least 24 hours prior to the rest of cohort ROC
Dosing in the abiraterone acetate SC cohorts will be sequential and will start with subjects in the lowest SC dosing cohort ie 25 mg Dosing will not begin in the next highest SC dose cohort until all safety data as well as available PK Pharmacokinetic data and TT levels from the previous cohorts have been reviewed by the safety review committee SRC eg Sponsor and Investigator and it has been deemed safe to proceed to the next highest dose
Dosing in the oral abiraterone acetate cohort Cohort 4 may begin at any time during the study
Thirty-two healthy adult men will be randomly assigned to a treatment cohort and will receive either a single Subcutaneous SC dose of ATRS-2002 abiraterone acetate or a single oral dose of the commercially available formulation of abiraterone acetate Zytiga Additionally for Cohorts 1 through 3 a single subject will be randomized as a sentinel subject to be dosed at least 24 hours prior to the rest of cohort ROC
Dosing in the abiraterone acetate SC cohorts will be sequential and will start with subjects in the lowest SC dosing cohort ie 25 mg Dosing will not begin in the next highest SC dose cohort until all safety data as well as available PK Pharmacokinetic data and TT levels from the previous cohorts have been reviewed by the safety review committee SRC eg Sponsor and Investigator and it has been deemed safe to proceed to the next highest dose
Dosing in the oral abiraterone acetate cohort Cohort 4 may begin at any time during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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