CachexiaPhase 1NCT06028321
Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
A Phase 1 study testing Part 1 Group 1 Regime A (ACM-001.1), Part 1 Group 2 Regimen C (Pindolol) and Part 2 Group D (Pindolol) in people with Cachexia, run by Actimed Therapeutics Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- What is being tested?
- Part 1 Group 1 Regime A (ACM-001.1), Part 1 Group 2 Regimen C (Pindolol) and Part 2 Group D (Pindolol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2021to 2 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females
- Aged 20 to 45 years inclusive at the time of signing informed consent
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
- Weight of 50 to 100 kg at screening
Who cannot join
- Subjects who had received any investigational medicinal product in a clinical research study within the 90 days prior to Day 1,
- Subjects for whom pindolol was contraindicated: hypersensitivity to the active substance or to any of its listed excipients.
- Evidence of current Severe Acute Respiratory Coronavirus 2 infection.
- History of any drug or alcohol abuse in the past 2 years.
- Females of childbearing potential who were pregnant or lactating.
- History of clinically significant cardiovascular disease, Raynaud's disease or phenomenon, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder.
- Subjects who were found to have mean heart rate less than 50 bpm at rest or mean systolic blood pressure (BP) less than 100 mmHg or mean diastolic heart rate less than 50 mmHg.
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug or herbal remedies (other than paracetamol, hormonal replacement therapy/hormonal contraception). Pindolol should not be taken in conjunction with agents which inhibit calcium transport.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Conditions
- Cachexia
- Being tested
- 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 )
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 Group 1 Regime A (ACM-001.1)Drug
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.
Part 1 Group 2 Regimen C (Pindolol)Drug
Drug: Pindolol tablets for oral use.
Part 2 Group D (Pindolol)Drug
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.
Part 2 Group E (ACM-001.1)Drug
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.
Part 2 Group F (ACM-001.1 )Drug
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.
Part 2 Group G (ACM-001.1)Drug
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.
Part 1 Group 1 Regimen B (Pindolol)Drug
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.
Part 1 Group 1 Regimen A (Placebo)Other
Placebo for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.
Part 2 Group E (Placebo)Other
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.
Part 2 Group F (Placebo)Other
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.
Part 2 Group G ( Placebo)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Group1 (AB) | Experimental | Part 1 Group1 Subjects were randomised to two treatment regimens (A and B) and received treatment sequence AB in a 2-period cross over.
Regimen A = 15 mg ACM-001.1 and matching placebo. Regimen B = 30 mg pindolol. Receives: Drug: Part 1 Group 1 Regime A (ACM-001.1); Drug: Part 1 Group 1 Regimen B (Pindolol); Other: Part 1 Group 1 Regimen A (Placebo) |
| Part 1 Group 1 (BA) | Experimental | Subjects were randomised to two treatment regimens (A and B) and received treatment sequence BA in a 2-period cross over.
Regimen B = 30 mg pindolol. Regimen A = 15 mg ACM-001.1 and matching placebo. Receives: Drug: Part 1 Group 1 Regime A (ACM-001.1); Drug: Part 1 Group 1 Regimen B (Pindolol); Other: Part 1 Group 1 Regimen A (Placebo) |
| Part 1 Group 2 (C) | Experimental | Subjects were non-randomised; received regimen C in parallel with Group 1 in a single period.
Regimen C = 15 mg pindolol. Receives: Drug: Part 1 Group 2 Regimen C (Pindolol) |
| Part 2 Group D | Experimental | Subjects received one of the four regimens over a four day treatment period. Regimen D = 20 mg pindolol BID (bis in die) for four days. Receives: Drug: Part 2 Group D (Pindolol) |
| Part 2 Group E | Experimental | Subjects received one of the four regimens over a four day treatment period. Regimen E = 5 mg ACM-001.1 and placebo BID for four days. Receives: Drug: Part 2 Group E (ACM-001.1); Other: Part 2 Group E (Placebo) |
| Part 2 Group F | Experimental | Subjects received one of the four regimens over a four day treatment period. Regimen F = 10 mg ACM-001.1 and placebo BID for four days. Receives: Drug: Part 2 Group F (ACM-001.1 ); Other: Part 2 Group F (Placebo) |
| Part 2 Group G | Experimental | Subjects received one of the four regimens over a four day treatment period. Regimen G = 15 mg ACM-001.1 and placebo BID for four days. Receives: Drug: Part 2 Group G (ACM-001.1); Other: Part 2 Group G ( Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Composite of PK parameters following single doses
Comparative bioavailability of S- pindolol and pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite].
Measured: Up to 5 days
Part 1 PK parameters following single doses
Comparative bioavailability of S- pindolol and pindolol include:maximum observed concentration (Cmax)
Measured: Up to 5 days
Part 1 PK parameters following single doses
Comparative bioavailability of S- pindolol and pindolol include:time of occurrence of Cmax (Tmax)
Measured: Up to 5 days
PK parameters following single doses
Comparative PK parameters of S- pindolol and racemic pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]).
Measured: Up to 5 days
PK parameters following single doses
Comparative PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax)
Measured: Up to 5 days
PK parameters following single doses
Comparative PK parameters of S- pindolol and racemic pindolol include: t time of occurrence of Cmax (Tmax)
Measured: Up to 5 days
Stoichiometric dose relationship measured using PK parameters following single doses
PK parameters of S- pindolol and racemic pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite])
Measured: Up to 5 days
Stoichiometric dose relationship measured using PK parameters following single doses
PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax).
Measured: Up to 5 days
Part 2 Composite of PK parameters following multiple doses in plasma
PK parameters of S- pindolol/racemic pindolol:Area under the curve for interval between doses (tau) (AUC(0 tau);Area under the concentration-time curve from time zero (pre-dose) to last time of measurable concentration (AUC[0-t])
Measured: Up to 6 days
Part 2 Composite of PK parameters following multiple doses in plasma
PK parameters of S- pindolol/racemic pindolol: Maximum observed concentration (Cmax),
Measured: Up to 6 days
Part 2 Composite of PK parameters following multiple doses in plasma
PK parameters of S- pindolol/racemic pindolol: Time to first occurrence of Cmax from plasma concentration-time data(Tmax).
Measured: Up to 6 days
Pharmacodynamics of ACM-001.1: Cardiovascular vital parameter- heart rate
Heart rate (beats per minute)
Measured: Up to 6 days
Cardiovascular vital parameter- blood pressure
Systolic blood pressure (mmHG) and diastolic blood pressure (mmHG)
Measured: Up to 6 days
Serum biomarker- DHEA/Cortisol
Dehydroepiandrosterone (DHEA)/Cortisol (ng/mL). Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours
Serum biomarker- Myostatin
Myostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker- Folistatin
Folistatin (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker-IGF1
Insulin-like growth factor (IGF)1 (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - (Type 3 procollagen peptide) PIIINP
PIIINP (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - monokine-induced by gamma interferon (MIG/CXL9) Leptin
Leptin (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - epithelial neutrophil activating peptide 78 (ENA78)
ENA78 (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - Ghrelin
Ghrelin (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - Growth Hormone Receptor Hormone
Growth Hormone Receptor Hormone (ng/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Serum biomarker - Somatostatin
Somatostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Measured: Day 1 at pre-dose (baseline). Day 4 at pre-dose, 1.5 hours.
Secondary outcomes (6)
Part 1 Composite PK parameters in urine following single doses
PK parameters of S-pindolol, R-pindolol and pindolol: Amount excreted (Ae), Cumulative amount excreted (CumAe), Fraction of dose excreted (%Ae) and Cumulative fraction of dose excreted (%CumAe)
Measured: Up to 5 days
Part 2 Composite PK parameters in urine following multiple doses and pindolol
PK parameters of S-pindolol, R-pindolol and pindolol: Amount excreted (Ae), Cumulative amount excreted (CumAe), Fraction of dose excreted (%Ae) and Cumulative fraction of dose excreted (%CumAe)
Measured: Up to 7 days
Part 1 and Part 2 Analysis of S-pindolol and R-pindolol concentrations in plasma for any in vivo conversion
Plasma concentrations were determined using validated analytical methods.
Measured: Up to 4 days
Part 1 Number of participants with adverse events following single doses as a measure of safety and tolerability
AEs will be collected from provision of written informed consent until discharge at the follow-up contact.
Measured: From screening: day -28 to follow up call on day 8 (part 1), up to 36 days.
Part 2 Number of participants with adverse events following single doses as a measure of safety and tolerability
AEs will be collected from provision of written informed consent until discharge at the follow-up contact
Measured: From screening: day -28 to follow up call on day 11 (part 2), up to 39 days.
Part 2 only - Pulmonary function test
Forced expiratory spirometry to determine parameters FEV1, FVC, FEV1/FVC
Measured: Up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 Nov 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actimed Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028321
- Sponsor's protocol ID
- ACM-2021-1-CT
- Other IDs
- QSC205141
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39665235
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06028321
- Acronym / sponsor ID
- ACM-2021-1-CT
- Conditions
- Cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Actimed Therapeutics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1 Group1 (AB) | Experimental | Drug: Part 1 Group 1 Regime A (ACM-001.1), Drug: Part 1 Group 1 Regimen B (Pindolol), Other: Part 1 Group 1 Regimen A (Placebo)Part 1 Group1 Subjects were randomised to two treatment regimens (A and B) and received treatment sequence AB in a 2-period cross over. Regimen A = 15 mg ACM-001.1 and matching placebo. Regimen B = 30 mg pindolol. |
| Part 1 Group 1 (BA) | Experimental | Drug: Part 1 Group 1 Regime A (ACM-001.1), Drug: Part 1 Group 1 Regimen B (Pindolol), Other: Part 1 Group 1 Regimen A (Placebo)Subjects were randomised to two treatment regimens (A and B) and received treatment sequence BA in a 2-period cross over. Regimen B = 30 mg pindolol. Regimen A = 15 mg ACM-001.1 and matching placebo. |
| Part 1 Group 2 (C) | Experimental | Drug: Part 1 Group 2 Regimen C (Pindolol)Subjects were non-randomised; received regimen C in parallel with Group 1 in a single period. Regimen C = 15 mg pindolol. |
| Part 2 Group D | Experimental | Drug: Part 2 Group D (Pindolol)Subjects received one of the four regimens over a four day treatment period. Regimen D = 20 mg pindolol BID (bis in die) for four days. |
| Part 2 Group E | Experimental | Drug: Part 2 Group E (ACM-001.1), Other: Part 2 Group E (Placebo)Subjects received one of the four regimens over a four day treatment period. Regimen E = 5 mg ACM-001.1 and placebo BID for four days. |
| Part 2 Group F | Experimental | Drug: Part 2 Group F (ACM-001.1 ), Other: Part 2 Group F (Placebo)Subjects received one of the four regimens over a four day treatment period. Regimen F = 10 mg ACM-001.1 and placebo BID for four days. |
| Part 2 Group G | Experimental | Drug: Part 2 Group G (ACM-001.1), Other: Part 2 Group G ( Placebo)Subjects received one of the four regimens over a four day treatment period. Regimen G = 15 mg ACM-001.1 and placebo BID for four days. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males or non-pregnant, non-lactating healthy females
- Aged 20 to 45 years inclusive at the time of signing informed consent
- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
- Weight of 50 to 100 kg at screening
Key exclusion criteria (8 listed)
- Subjects who had received any investigational medicinal product in a clinical research study within the 90 days prior to Day 1,
- Subjects for whom pindolol was contraindicated: hypersensitivity to the active substance or to any of its listed excipients.
- Evidence of current Severe Acute Respiratory Coronavirus 2 infection.
- History of any drug or alcohol abuse in the past 2 years.
- Females of childbearing potential who were pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1 Group 1 Regime A (ACM-001.1)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 | Part 1 Group 1 (BA), Part 1 Group1 (AB) |
| Part 1 Group 2 Regimen C (Pindolol)Drug: Pindolol tablets for oral use. | Drug | Part 1 Group 2 (C) |
| Part 2 Group D (Pindolol)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 | Part 2 Group D |
| Part 2 Group E (ACM-001.1)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 | Part 2 Group E |
| Part 2 Group F (ACM-001.1 )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 | Part 2 Group F |
| Part 2 Group G (ACM-001.1)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 | Part 2 Group G |
| Part 1 Group 1 Regimen B (Pindolol)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. | Drug | Part 1 Group 1 (BA), Part 1 Group1 (AB) |
| Part 1 Group 1 Regimen A (Placebo)Placebo for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B. | Other | Part 1 Group 1 (BA), Part 1 Group1 (AB) |
| Part 2 Group E (Placebo)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. | Other | Part 2 Group E |
| Part 2 Group F (Placebo)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. | Other | Part 2 Group F |
| Part 2 Group G ( Placebo)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. | Other | Part 2 Group G |
Primary outcome
Part 1 Composite of PK parameters following single doses
Time frame: Up to 5 days
Comparative bioavailability of S- pindolol and pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite].
Part 1 PK parameters following single doses
Time frame: Up to 5 days
Comparative bioavailability of S- pindolol and pindolol include:maximum observed concentration (Cmax)
Part 1 PK parameters following single doses
Time frame: Up to 5 days
Comparative bioavailability of S- pindolol and pindolol include:time of occurrence of Cmax (Tmax)
PK parameters following single doses
Time frame: Up to 5 days
Comparative PK parameters of S- pindolol and racemic pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]).
PK parameters following single doses
Time frame: Up to 5 days
Comparative PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax)
PK parameters following single doses
Time frame: Up to 5 days
Comparative PK parameters of S- pindolol and racemic pindolol include: t time of occurrence of Cmax (Tmax)
Stoichiometric dose relationship measured using PK parameters following single doses
Time frame: Up to 5 days
PK parameters of S- pindolol and racemic pindolol include: area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite])
Stoichiometric dose relationship measured using PK parameters following single doses
Time frame: Up to 5 days
PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax).
Part 2 Composite of PK parameters following multiple doses in plasma
Time frame: Up to 6 days
PK parameters of S- pindolol/racemic pindolol:Area under the curve for interval between doses (tau) (AUC(0 tau);Area under the concentration-time curve from time zero (pre-dose) to last time of measurable concentration (AUC[0-t])
Part 2 Composite of PK parameters following multiple doses in plasma
Time frame: Up to 6 days
PK parameters of S- pindolol/racemic pindolol: Maximum observed concentration (Cmax),
Part 2 Composite of PK parameters following multiple doses in plasma
Time frame: Up to 6 days
PK parameters of S- pindolol/racemic pindolol: Time to first occurrence of Cmax from plasma concentration-time data(Tmax).
Pharmacodynamics of ACM-001.1: Cardiovascular vital parameter- heart rate
Time frame: Up to 6 days
Heart rate (beats per minute)
Cardiovascular vital parameter- blood pressure
Time frame: Up to 6 days
Systolic blood pressure (mmHG) and diastolic blood pressure (mmHG)
Serum biomarker- DHEA/Cortisol
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours
Dehydroepiandrosterone (DHEA)/Cortisol (ng/mL). Serum concentrations were determined using validated analytical method.
Serum biomarker- Myostatin
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Myostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker- Folistatin
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Folistatin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker-IGF1
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Insulin-like growth factor (IGF)1 (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - (Type 3 procollagen peptide) PIIINP
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
PIIINP (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - monokine-induced by gamma interferon (MIG/CXL9) Leptin
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Leptin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - epithelial neutrophil activating peptide 78 (ENA78)
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
ENA78 (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Ghrelin
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Ghrelin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Growth Hormone Receptor Hormone
Time frame: Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Growth Hormone Receptor Hormone (ng/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Somatostatin
Time frame: Day 1 at pre-dose (baseline). Day 4 at pre-dose, 1.5 hours.
Somatostatin (pg/mL).Serum concentrations were determined using validated analytical method.
6 secondary outcomes
Part 1 Composite PK parameters in urine following single doses
Time frame: Up to 5 days
Part 2 Composite PK parameters in urine following multiple doses and pindolol
Time frame: Up to 7 days
Part 1 and Part 2 Analysis of S-pindolol and R-pindolol concentrations in plasma for any in vivo conversion
Time frame: Up to 4 days
Part 1 Number of participants with adverse events following single doses as a measure of safety and tolerability
Time frame: From screening: day -28 to follow up call on day 8 (part 1), up to 36 days.
Part 2 Number of participants with adverse events following single doses as a measure of safety and tolerability
Time frame: From screening: day -28 to follow up call on day 11 (part 2), up to 39 days.
Part 2 only - Pulmonary function test
Time frame: Up to 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 39665235Misselwitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part 1 Group 1 Regime A (ACM-001.1), Part 1 Group 2 Regimen C (Pindolol) and Part 2 Group D (Pindolol) in people with Cachexia, run by Actimed Therapeutics Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Composite of PK parameters following single doses (time frame: Up to 5 days). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.