Status:
COMPLETED
Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV)
Lead Sponsor:
Actimed Therapeutics Ltd
Collaborating Sponsors:
Quotient Sciences
Conditions:
Cachexia
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
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 pin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06028321
Start Date
November 26 2021
End Date
June 2 2022
Last Update
October 10 2023
Active Locations (1)
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1
Quotient Sciences Ltd
Ruddington, United Kingdom, NG11 9JS