Evidence map›Paper›PMID 39665235›Full record

Trial reportJournal of cachexia, sarcopenia and muscle2025

Pharmacokinetics, Pharmacodynamics and Bioavailability of ACM-001.1 (S-Pindolol Benzoate) in Healthy Volunteers.

Frank Misselwitz, Dennis Henderson, Somasekhara R Menakuru, Elaine Morten, Chris Roe, Gareth Whitaker, Stefan Wohlfeil, John McDermott

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Journal of cachexia, sarcopenia and muscle, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06028321 (Two Part Study to Assess Comparative Bioavailability, Pharmacokinetics of a Single Dose of ACM-001.1, Two Single Doses of Pindolol), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06028321 phase1completednot on this map

Two Part Study to Assess Comparative Bioavailability, Pharmacokinetics of a Single Dose of ACM-001.1, Two Single Doses of Pindolol (Part1) Followed by Evaluation of Steady State Pharmacokinetics, Pharmacodynamics of ACM-001.1 in HV (Part2)

TypeinterventionalSponsorActimed Therapeutics LtdRan2021 to 2022Enrolled51ConditionsCachexiaArmsPart 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 )
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Frank MisselwitzActimed Therapeutics, London, UK.ORCID 0000-0003-1366-7958
Dennis HendersonQuotient Sciences, Nottingham, UK.
Somasekhara R MenakuruQuotient Sciences, Nottingham, UK.
Elaine MortenActimed Therapeutics, London, UK.
Chris RoeQuotient Sciences, Nottingham, UK.
Gareth WhitakerQuotient Sciences, Nottingham, UK.
Stefan WohlfeilActimed Therapeutics, London, UK.
John McDermottQuotient Sciences, Nottingham, UK.

Funding

Actimed Therapeutics, London, UK
6 · The paper itself

Abstract

backgroundS-pindolol has metabolic effects of potential benefit in cancer cachexia: reduced catabolism through nonselective β-blockade; increased anabolism through partial β2 receptor agonism; and increased appetite and reduced fatigue through central 5-hydroxytryptamine/serotonin receptor activity. A Phase 2a clinical trial demonstrated that S-pindolol can reverse weight loss and improve fat-free mass in patients with cancer-related weight loss. A comparative phase I bioavailability study of S-pindolol and racemic pindolol was performed to support the development of S-pindolol in cancer cachexia.

methodsThis two-part study assessed the comparative bioavailability and pharmacokinetics of single doses of S-pindolol benzoate (ACM-001.1) or pindolol (Part 1) and the steady-state pharmacokinetics and pharmacodynamics of multiple doses of ACM-001.1 and pindolol (Part 2) in healthy volunteers (NCT06028321). ACM-001.1 5, 10 and 15 mg and pindolol 15, 20 and 30 mg were tested. In Part 1, subjects were randomised to ACM-001.1 15 mg followed after a 48-h washout period by pindolol 30 mg, or the reverse sequence; another group received pindolol 15 mg. Subjects in Part 2 were randomised to pindolol 20 mg twice-daily or ACM-001.1 5, 10 or 15 mg twice-daily for 4 days. Bioavailability, pharmacokinetics, pharmacodynamics, potential for and extent of stereoconversion, and tolerability were assessed.

resultsParts 1 and 2 included 24 and 27 healthy volunteers, respectively. ACM-001.1 had predictable pharmacokinetics up to a dose of 15 mg twice daily, with low intersubject variability, after single and multiple doses (T

conclusionsData from this bridging study of enantiomerically pure ACM-001.1 and its parent racemic drug, pindolol, support clinical trials of ACM-001.1 for the treatment of cancer cachexia.

Indexed as

Biological AvailabilityHealthy VolunteersPindololAdultCOVID-19 VaccinesFemaleHumansMaleMiddle AgedVaccines, SyntheticYoung AdultACM-001 COVID-19 vaccineCOVID-19 VaccinesPindololVaccines, SyntheticACM‐001.1bioequivalencecancer cachexiapharmacodynamicspharmacokineticsstereoconversion

Identifiers

PMID39665235
PMCPMC11670174

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.