Phase 1 Irritable Bowel Syndrome 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:

• Healthy volunteers aged 18 to 45 years (inclusive) who identify as Caucasian
• People confirmed to be in good health, with no significant abnormalities found during medical history review, physical examination, lab tests, or other checks outlined in the study protocol
• People with a blood pressure reading within a specific healthy range: systolic (top number) between 100 and 130 mmHg, and diastolic (bottom number) between 70 and 89 mmHg
• People with a resting heart rate between 60 and 89 beats per minute
• People with a breathing rate between 12 and 20 breaths per minute
• People with a body temperature between 36.0°C and 36.9°C
• People with a body mass index (BMI) between 18.5 and 30 kg/m², and a minimum body weight of at least 55 kg for men or at least 45 kg for women
• People who agree to use effective contraception throughout the study and for 30 days after it ends; women who could become pregnant must also have a negative urine pregnancy test before joining
• People who have personally read and voluntarily signed a consent form before any study-related procedures take place

Who may not be able to join:

• People with a history of significant allergic conditions
• People with a known sensitivity or intolerance to any ingredients in the study drug or the comparison drug
• People with known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
• People with chronic (long-term) conditions affecting the kidneys, liver, digestive system, heart and blood vessels, lymphatic system, lungs, nervous system, hormonal system, muscles and bones, urinary or reproductive system, immune system, skin, blood-forming organs, or eyes
• People who have had surgery on the digestive tract (an appendix removal performed at least one year before the study screening is an exception)
• People with any condition that, in the investigator's opinion, could affect how the study drug is absorbed, distributed, broken down, or removed by the body
• People who had an acute infection within the 4 weeks before screening
• People who used medications that significantly affect blood circulation or liver function (such as barbiturates, omeprazole, or cimetidine) within 2 months before screening
• People who regularly used any medications within 2 weeks before screening, or used any medication even once within 7 days before screening — including over-the-counter drugs, vitamins, supplements, or herbal products
• People who donated blood or plasma within 3 months before screening
• Women who used hormonal contraceptives within 2 months before screening
• People who received a long-acting (depot) injection of any medication within 3 months before screening
• Women who are pregnant or breastfeeding, or who have a positive urine pregnancy test
• Women of childbearing potential who had unprotected sexual intercourse with a partner who has not been surgically sterilised within 30 days before taking the study drug
• People who participated in another clinical trial within 3 months before screening, or who are currently in another clinical trial
• People who drank more than 10 units of alcohol per week in the month before joining the study, or who have a history of alcoholism, drug addiction, or substance misuse (1 unit = 500 ml beer, 200 ml wine, or 50 ml spirits)
• People who currently smoke more than 10 cigarettes per day, or who smoked that amount in the 6 months before screening, or who are unwilling to refrain from smoking during their hospital stay
• People who consumed alcohol, caffeine, or caffeine-containing products within 7 days before taking the study drug
• People who consumed citrus fruits, cranberries, rose hips, or any products containing them, or products containing St. John's wort, within 7 days before taking the study drug
• People who experienced dehydration from diarrhoea, vomiting, or other causes in the 24 hours before taking the study drug
• People who test positive for HIV, syphilis, hepatitis B, or hepatitis C during screening
• People with a history of, or current, abnormalities on an ECG (heart tracing)
• People who test positive for narcotic substances or controlled medications in a urine test during screening
• People who test positive for alcohol in a breath test during screening
• People who plan to be hospitalised during the study for any reason other than the hospitalisations required by the study itself
• People who are unable or unwilling to follow the study requirements, including dietary and activity restrictions
• People belonging to certain groups considered vulnerable, including (but not limited to) medical, pharmacy, or dental students; junior clinic or laboratory staff; pharmaceutical company employees; military personnel; prisoners; care facility residents; people with low income or who are unemployed; members of ethnic minorities; homeless individuals; refugees; people under guardianship; people unable to give informed consent; and law enforcement personnel
• People who follow fasting or special diets (such as vegetarianism, veganism, or salt-restricted diets), or who have lifestyles such as night-shift work or extreme physical training, that in the investigator's opinion would make participation unsuitable

Reasons a person may be removed from the trial after it begins include:

• Choosing to withdraw from the study
• Not following study rules (such as missing procedures, taking prohibited medications, or not following diet and lifestyle restrictions)
• Developing a situation during the study that puts their safety at risk (such as an allergic reaction)
• Being found not to meet the eligibility criteria after enrolment
• Experiencing a serious unwanted health event during the study
• Needing to start a treatment that could interfere with how the study drug behaves in the body
• Missing two or more blood samples in a row, or three or more blood samples within one study period
• Experiencing vomiting or diarrhoea within 6 hours of taking the study drug
• Testing positive for narcotic substances or alcohol during the study
• A positive pregnancy test result during the study (for women)
• Any other circumstance that prevents the study from being carried out according to the plan

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