First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males (NCT06094283) | Clinical Trial Compass
CompletedPhase 1
First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males
United Kingdom16 participantsStarted 2023-12-20
Plain-language summary
A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects.
Who can participate
Age range
25 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male subject in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of Screening.
. Subject must provide written informed consent.
. Subject must be willing and able to communicate and participate in the whole study.
. Subject is 25 to 60 years of age (inclusive).
. Subject has been vasectomized for at least 6 months prior to enrolment
. Subject has body mass index (BMI) 18.0 to 32.0 kg/m2.
. Subject has no history of hormonal therapy uses in the 90 days prior to the first screening visit.
. Subject agrees to use a condom during the study until the final return visit to ensure the safety of the study participants and their sexual partner(s)
Exclusion criteria
. Men participating in another clinical study involving an investigational drug within the last 90 days prior to the first dosing or less than 5 elimination half-lives prior to first dosing, whichever is longer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Timeframe: Baseline to 43 days for subjects participating in Cohorts 1 and 2 participating in the 2 periods; Baseline to 10 weeks for Cohorts 1 and 2 that also complete the fed portion of the study; and Baseline to 16 weeks if waiting for other cohorts to finish
. Clinically significant abnormal physical and/or laboratory findings at Screening
. Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant, such as bilirubin of \>20 micro mol/L and ALT, AST, GGT and ALP above the upper limit of normal.
. Evidence of renal impairment at screening, as indicated by an estimated eGFR of \<80 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI; 2009) equation.
. Use of androgens within 90 days before first screening visit.
. Ongoing use of body building nutritional supplements.
. Systolic blood pressure (BP) \>140 mmHg (\<45 years) or \>160 mmHg (≥45 years) and diastolic BP \>90 mmHg at screening or predose.
. Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval in ECG (QTc) interval of \>450 msec at screening or predose.