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

Primary Purpose

Cachexia

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
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)
Sponsored by
Actimed Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Quotient Sciences Ltd

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1 Group1 (AB)

Part 1 Group 1 (BA)

Part 1 Group 2 (C)

Part 2 Group D

Part 2 Group E

Part 2 Group F

Part 2 Group G

Arm Description

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.

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.

Subjects were non-randomised; received regimen C in parallel with Group 1 in a single period. Regimen C = 15 mg 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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].
Part 1 PK parameters following single doses
Comparative bioavailability of S- pindolol and pindolol include:maximum observed concentration (Cmax)
Part 1 PK parameters following single doses
Comparative bioavailability of S- pindolol and pindolol include:time of occurrence of Cmax (Tmax)
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]).
PK parameters following single doses
Comparative PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax)
PK parameters following single doses
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
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
PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax).
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])
Part 2 Composite of PK parameters following multiple doses in plasma
PK parameters of S- pindolol/racemic pindolol: Maximum observed concentration (Cmax),
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).
Pharmacodynamics of ACM-001.1: Cardiovascular vital parameter- heart rate
Heart rate (beats per minute)
Cardiovascular vital parameter- blood pressure
Systolic blood pressure (mmHG) and diastolic blood pressure (mmHG)
Serum biomarker- DHEA/Cortisol
Dehydroepiandrosterone (DHEA)/Cortisol (ng/mL). Serum concentrations were determined using validated analytical method.
Serum biomarker- Myostatin
Myostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker- Folistatin
Folistatin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker-IGF1
Insulin-like growth factor (IGF)1 (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - (Type 3 procollagen peptide) PIIINP
PIIINP (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - monokine-induced by gamma interferon (MIG/CXL9) Leptin
Leptin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - epithelial neutrophil activating peptide 78 (ENA78)
ENA78 (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Ghrelin
Ghrelin (pg/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Growth Hormone Receptor Hormone
Growth Hormone Receptor Hormone (ng/mL).Serum concentrations were determined using validated analytical method.
Serum biomarker - Somatostatin
Somatostatin (pg/mL).Serum concentrations were determined using validated analytical method.

Secondary Outcome Measures

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)
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)
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.
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.
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
Part 2 only - Pulmonary function test
Forced expiratory spirometry to determine parameters FEV1, FVC, FEV1/FVC

Full Information

First Posted
July 6, 2023
Last Updated
October 6, 2023
Sponsor
Actimed Therapeutics Ltd
Collaborators
Quotient Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06028321
Brief Title
Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actimed Therapeutics Ltd
Collaborators
Quotient Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
Part 2 was single - blind study (subject blinded). Masking was not triple for all parts of the study or all arms.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Group1 (AB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1 Group 1 (BA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 1 Group 2 (C)
Arm Type
Experimental
Arm Description
Subjects were non-randomised; received regimen C in parallel with Group 1 in a single period. Regimen C = 15 mg pindolol.
Arm Title
Part 2 Group D
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 Group E
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 Group F
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 Group G
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 1 Group 1 Regime A (ACM-001.1)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 1 Group 2 Regimen C (Pindolol)
Intervention Description
Drug: Pindolol tablets for oral use.
Intervention Type
Drug
Intervention Name(s)
Part 2 Group D (Pindolol)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 2 Group E (ACM-001.1)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 2 Group F (ACM-001.1 )
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 2 Group G (ACM-001.1)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Part 1 Group 1 Regimen B (Pindolol)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Part 1 Group 1 Regimen A (Placebo)
Intervention Description
Placebo for oral use. Subjects randomised to Regimen A received placebo tablets to match the tablet number received by subjects in Regimen B.
Intervention Type
Other
Intervention Name(s)
Part 2 Group E (Placebo)
Intervention Description
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 Type
Other
Intervention Name(s)
Part 2 Group F (Placebo)
Intervention Description
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 Type
Other
Intervention Name(s)
Part 2 Group G ( Placebo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1 Composite of PK parameters following single doses
Description
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].
Time Frame
Up to 5 days
Title
Part 1 PK parameters following single doses
Description
Comparative bioavailability of S- pindolol and pindolol include:maximum observed concentration (Cmax)
Time Frame
Up to 5 days
Title
Part 1 PK parameters following single doses
Description
Comparative bioavailability of S- pindolol and pindolol include:time of occurrence of Cmax (Tmax)
Time Frame
Up to 5 days
Title
PK parameters following single doses
Description
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]).
Time Frame
Up to 5 days
Title
PK parameters following single doses
Description
Comparative PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax)
Time Frame
Up to 5 days
Title
PK parameters following single doses
Description
Comparative PK parameters of S- pindolol and racemic pindolol include: t time of occurrence of Cmax (Tmax)
Time Frame
Up to 5 days
Title
Stoichiometric dose relationship measured using PK parameters following single doses
Description
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])
Time Frame
Up to 5 days
Title
Stoichiometric dose relationship measured using PK parameters following single doses
Description
PK parameters of S- pindolol and racemic pindolol include: maximum observed concentration (Cmax).
Time Frame
Up to 5 days
Title
Part 2 Composite of PK parameters following multiple doses in plasma
Description
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])
Time Frame
Up to 6 days
Title
Part 2 Composite of PK parameters following multiple doses in plasma
Description
PK parameters of S- pindolol/racemic pindolol: Maximum observed concentration (Cmax),
Time Frame
Up to 6 days
Title
Part 2 Composite of PK parameters following multiple doses in plasma
Description
PK parameters of S- pindolol/racemic pindolol: Time to first occurrence of Cmax from plasma concentration-time data(Tmax).
Time Frame
Up to 6 days
Title
Pharmacodynamics of ACM-001.1: Cardiovascular vital parameter- heart rate
Description
Heart rate (beats per minute)
Time Frame
Up to 6 days
Title
Cardiovascular vital parameter- blood pressure
Description
Systolic blood pressure (mmHG) and diastolic blood pressure (mmHG)
Time Frame
Up to 6 days
Title
Serum biomarker- DHEA/Cortisol
Description
Dehydroepiandrosterone (DHEA)/Cortisol (ng/mL). Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours
Title
Serum biomarker- Myostatin
Description
Myostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker- Folistatin
Description
Folistatin (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker-IGF1
Description
Insulin-like growth factor (IGF)1 (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - (Type 3 procollagen peptide) PIIINP
Description
PIIINP (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - monokine-induced by gamma interferon (MIG/CXL9) Leptin
Description
Leptin (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - epithelial neutrophil activating peptide 78 (ENA78)
Description
ENA78 (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - Ghrelin
Description
Ghrelin (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - Growth Hormone Receptor Hormone
Description
Growth Hormone Receptor Hormone (ng/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose. Day 4 at pre-dose, 1.5 hours.
Title
Serum biomarker - Somatostatin
Description
Somatostatin (pg/mL).Serum concentrations were determined using validated analytical method.
Time Frame
Day 1 at pre-dose (baseline). Day 4 at pre-dose, 1.5 hours.
Secondary Outcome Measure Information:
Title
Part 1 Composite PK parameters in urine following single doses
Description
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)
Time Frame
Up to 5 days
Title
Part 2 Composite PK parameters in urine following multiple doses and pindolol
Description
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)
Time Frame
Up to 7 days
Title
Part 1 and Part 2 Analysis of S-pindolol and R-pindolol concentrations in plasma for any in vivo conversion
Description
Plasma concentrations were determined using validated analytical methods.
Time Frame
Up to 4 days
Title
Part 1 Number of participants with adverse events following single doses as a measure of safety and tolerability
Description
AEs will be collected from provision of written informed consent until discharge at the follow-up contact.
Time Frame
From screening: day -28 to follow up call on day 8 (part 1), up to 36 days.
Title
Part 2 Number of participants with adverse events following single doses as a measure of safety and tolerability
Description
AEs will be collected from provision of written informed consent until discharge at the follow-up contact
Time Frame
From screening: day -28 to follow up call on day 11 (part 2), up to 39 days.
Title
Part 2 only - Pulmonary function test
Description
Forced expiratory spirometry to determine parameters FEV1, FVC, FEV1/FVC
Time Frame
Up to 32 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Quotient Sciences Ltd
City
Ruddington
ZIP/Postal Code
NG11 9JS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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