Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
Cachexia
About this trial
This is an interventional treatment trial for Cachexia
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.
Sites / Locations
- Quotient Sciences Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
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
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.