Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028321
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-07-06
Brief Title:
Study of Comparative Bioavailability and Pharmacokinetics of ACM-0011 and Pindolol in Healthy Volunteers HV
Sponsor:
Actimed Therapeutics Ltd
Organization:
Actimed Therapeutics Ltd
Study Overview
Official Title:
Two Part Study to Assess Comparative Bioavailability Pharmacokinetics of a Single Dose of ACM-0011 Two Single Doses of Pindolol Part1 Followed by Evaluation of Steady State Pharmacokinetics Pharmacodynamics of ACM-0011 in HV Part2
Status:
COMPLETED
Status Verified Date:
2023-10
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 early phase two-part study was to compare the bioavailability BA pharmacokinetics PK and pharmacodynamics PD of racemic pindolol with the benzoate salt of the S-enantiomer of pindolol ACM-0011 and provide safety information A total of 51 healthy male and female subjects were enrolled and 48 healthy subjects completed the study
Part 1 consisted of two Groups to compare BA and PK Group 1 received two treatment sequences of a single dose of ACM-0011 versus racemic pindolol Group 2 ran in parallel with Group 1 and assessed the PK of a single dose of racemic pindolol in a single period
Part 2 consisted of four groups to evaluate the steady state PK and PD of ACM-0011 with multiple ascending doses over 4 days
Part 1 consisted of two Groups to compare BA and PK Group 1 received two treatment sequences of a single dose of ACM-0011 versus racemic pindolol Group 2 ran in parallel with Group 1 and assessed the PK of a single dose of racemic pindolol in a single period
Part 2 consisted of four groups to evaluate the steady state PK and PD of ACM-0011 with multiple ascending doses over 4 days
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| QSC205141 | OTHER | Quotient Sciences | None |