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 range25 Years – 60 Years
SexMALE
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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.
✕. 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.
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