Phase 1 Hypertension Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to take part voluntarily, understand what the study involves and any risks, sign a consent form, and agree to follow the study rules
• People aged between 18 and 50 years old (inclusive) who are healthy volunteers
• People whose Body Mass Index (BMI) is between 18 and 26, and who weigh at least 50 kg (if male) or at least 45 kg (if female)
• People who are in generally good health, with no signs of significant illness, as confirmed by the study doctor through a full health check including blood tests, heart tracing (ECG), and chest X-ray
• Women who could become pregnant must agree to use highly effective contraception throughout the study and for 3 months after the last dose, and must have a negative pregnancy blood test at the start
• Men must agree to use effective contraception throughout the study and for 3 months after the last dose

Who may not be able to join:

• People with a known allergy to aldosterone synthase inhibitors or any ingredient in the study drug
• People with a significant medical history involving the hormonal, heart, lung, digestive, liver, kidney, or nervous system (including a history of seizures), or any significant mental health condition
• People with any known condition that could affect how the body absorbs, processes, or removes a drug, such as swallowing difficulties, gut diseases, or previous stomach or bowel surgery
• People who received a live or weakened vaccine within 4 weeks before the screening visit or during the trial (flu vaccines are an exception)
• People who drink more than 8 cups (250 mL each) of tea, coffee, or caffeinated drinks per day, or who consumed these within 48 hours before taking the study drug, or who are unable to stop during the trial; also people who regularly consume large amounts of xanthine-rich foods or grapefruit, or who had any within 48 hours before dosing
• People who smoke or used nicotine products at an average of 5 or more cigarettes per day in the 3 months before screening, or who are unable to stop using tobacco or nicotine products (including patches, chewing tobacco, cigars, or pipes) during the trial
• People who took part in another clinical drug trial and received an experimental drug within 3 months before the first dose in this trial
• People who used corticosteroid medications within 3 months before the first dose
• People who donated blood, lost 400 mL or more of blood, or received a blood transfusion or blood products within 3 months before the first dose, or who plan to donate blood during the trial or within 30 days after the last dose
• People who drank heavily or regularly in the 3 months before screening (defined as more than 14 standard drinks per week on average), had a positive breath alcohol test at screening, or are unable to avoid alcohol during the trial
• People who test positive on a drug screening test, have a history of substance misuse in the past 5 years, or used recreational drugs in the 3 months before screening
• People whose blood pressure or pulse rate falls outside the acceptable ranges at screening, or who experience a significant drop in blood pressure when standing up (postural hypotension)
• People who test positive at screening for hepatitis B, hepatitis C, HIV, or syphilis
• People with an active, uncontrolled infection (bacterial, viral, fungal, or parasitic) that has not been treated and resolved
• People who used any medication — including prescription drugs, over-the-counter medicines, herbal products, vitamins, or supplements — within 14 days before the first dose (or within 5 half-lives of that medication, whichever is longer) if the study doctor believes it could affect the study results or safety assessment
• People whose blood potassium level is too low (below 3.5 mmol/L) or too high (5.0 mmol/L or above) at screening or on admission
• People with elevated liver enzyme levels (AST, ALT) or total bilirubin above 1.5 times the normal upper limit at screening or admission
• People with reduced kidney function, as measured by a standard calculation (eGFR below 90 mL/min/1.73m²)
• People with a personal or family history of certain heart rhythm conditions (long or short QT syndrome), fainting, a specific dangerous heart rhythm (torsades de pointes), heart failure, or significant slow heart rate; also people with uncontrolled low levels of potassium, calcium, or magnesium; and, for a specific part of the trial, people who used heart or rhythm medications within 4 weeks before the first dose, or who have a prolonged QTcF interval on their heart tracing (above 450 milliseconds)
• People with other significant abnormal findings on their heart tracing (ECG) at screening or admission, as judged by the study doctor; also people who plan to do intense physical exercise (such as long-distance running or weightlifting) from 7 days before dosing until the end of the study
• People whom the study doctor considers unsuitable for participation for any other reason

Important: Always verify eligibility with the trial site directly before applying.