Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)

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.

Timeline

Start

2021-11-26

Primary completion

2022-06-02

Completion

2022-06-02

Publications

• Misselwitz F, Henderson D, Menakuru SR, Morten E, Roe C, Whitaker G, Wohlfeil S, McDermott J. Pharmacokinetics, Pharmacodynamics and Bioavailability of ACM-001.1 (S-Pindolol Benzoate) in Healthy Volunteers. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13651. doi: 10.1002/jcsm.13651. Epub 2024 Dec 12.

Drugs

Indications