Phase 1 Hypertension Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 19 years or older at the time of the screening visit.
• People who weigh at least 50 kg and have a body mass index (BMI) between 18.0 and 30.0 at screening (BMI is a measure calculated from height and weight).
• People with no ongoing or long-term medical conditions that require treatment, and no concerning signs found during a medical examination.
• People whose blood tests, vital signs, physical examination, and heart tracing (ECG) results at screening are considered suitable by the trial team, based on the nature of the medicine being studied.
• People who have fully understood the trial details, are willing to take part voluntarily, and have signed a written consent form agreeing to follow the study requirements.

Who may not be able to join:

• People who have, or have had, a significant medical condition affecting the liver, kidneys, nervous system, mental health, lungs, hormone system, blood, cancer, urinary or reproductive system, heart, digestive system, or muscles and joints.
• Women who are pregnant (based on a urine test) or currently breastfeeding.
• People with a history of severe allergic reactions (such as anaphylaxis or severe swelling) to the active or inactive ingredients in the trial medicine, or to other medicines such as aspirin, penicillin, or macrolide antibiotics.
• People with a history of stomach or bowel conditions, or surgeries that could affect how the body absorbs medicine — for example, Crohn's disease, ulcers, or pancreatitis (simple appendix or hernia surgery are exceptions).
• People whose heart tracing (ECG) at screening shows certain abnormalities, including a QTc interval above 450 ms for males or 470 ms for females, a PR interval above 200 ms, or a QRS duration above 120 ms (confirm with trial site if these terms are unfamiliar).
• People whose blood test results at screening show liver enzyme levels more than twice the normal upper limit, or kidney function results outside the normal range.
• People with a history of substance abuse, or who test positive for drugs of abuse in a urine screening test.
• People whose blood pressure or pulse at screening (after at least 3 minutes of seated rest) falls outside acceptable ranges — specifically, systolic blood pressure at or below 90 or at or above 150 mmHg, diastolic blood pressure at or below 60 or at or above 100 mmHg, or a pulse rate at or below 40 or at or above 100 beats per minute.
• People who show signs of a significant drop in blood pressure when standing up (orthostatic hypotension) at screening.
• People who have used certain medicines that affect how the body processes drugs — such as barbiturates — within one month before the first dose.
• People who follow an unusual diet or regularly eat foods that could affect how the body handles medicines.
• People who have taken prescription medicines or herbal products within 2 weeks before the first dose, or over-the-counter medicines or dietary supplements within 10 days before the first dose, unless the trial doctor determines these would not affect the study medicine (confirm with trial site).
• People who have taken part in another clinical trial involving an experimental medicine within 6 months before the first dose.
• People who have donated whole blood within 2 months, donated platelets within 1 month, or received a blood transfusion within 1 month before the first dose — or who are unable to avoid blood donation from the time of consent through to the final study visit.
• People who have been drinking more than 21 units of alcohol per week in the 6 months before the first dose, or who are unable to avoid alcohol from the time of consent through to the final study visit (1 unit equals approximately 12.5 mL of pure alcohol).
• People who have been smoking more than 10 cigarettes per day in the 3 months before the first dose, or who are unable to avoid smoking from 24 hours before the first dose until the last blood sample is taken.
• People who have eaten grapefruit or grapefruit-containing foods within 72 hours before the first dose, or who are unable to avoid these until the final study visit.
• People who are unable to avoid caffeine-containing foods or drinks — such as coffee, tea, energy drinks, or cola — from 24 hours before the first dose until the last blood sample is taken.
• People who are unable to avoid intense physical exercise from 48 hours before the first dose until the final study visit.
• People who are planning to become pregnant, or who (or whose partner) are not using a reliable form of contraception from the time of consent until 90 days after the last dose of the study medicine.
• People who are considered unsuitable for any other reason, as determined by the trial investigator.

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