Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Part 1 Group 1 Regime A (ACM-001.1); Part 1 Group 2 Regimen C (Pindolol); Part 2 Group D (Pindolol); Part 2 Group E (ACM-001.1); Part 2 Group F (ACM-001.1 ); Part 2 Group G (ACM-001.1); Part 1 Group 1 Regimen B (Pindolol); Part 1 Group 1 Regimen A (Placebo); Part 2 Group E (Placebo); Part 2 Group F (Placebo); Part 2 Group G ( Placebo)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other; Other; Other; Other
Intervention description(s): Drug: ACM-001.1 immediate release tablets for oral use and matching placebo, and pindolol tablets for oral use.
Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.; Drug: Pindolol tablets for oral use.; Drug: Pindolol tablets for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Drug: ACM-001.1 immediate release tablets for oral use and matching placebo. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Drug: pindolol tablets for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.; Placebo for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.; Placebo for oral use. Subjects were dosed over a four day treatment period twice daily.
Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Placebo for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.; Placebo for oral use. Subjects were dosed over a four day treatment period twice daily. Subjects receiving ACM-001.1 in regimens E, F and G also received placebo tablets to match the tablet number received by subjects receiving pindolol in Regimen D.
Intervention MeSH terms: Pindolol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1: part - blinded, part randomized, partial cross- over study. Group 1: double - blinded and randomized to two treatment sequences in a two period cross- over.
Group 2: open label, non-randomized and in parallel with Group 1. Part 2: single-blind (subject blinded), randomized, parallel-group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment