Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
Status:
Completed
Trial end date:
2022-06-02
Target enrollment:
Participant gender:
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-001.1) 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-001.1 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-001.1 with
multiple ascending doses over 4 days.