Open Label, Repeat Dose Study Evaluating YCT-529 in Healthy Males
NCT Number: NCT06542237
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Male Contraception
Interventions: DRUG: YCT-529
Sponsor: YourChoice Therapeutics, Inc.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-12
Completion Date: 2026-02-28

Summary:
This is an open-label, 2 part-study, 28-day dose study of YCT-529 in healthy males who have decided to have a vasectomy and are waiting for the procedure and for men who have decided not to father children in the future. The study is aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and to assess sexual function and mood.

Primary Outcome Measures: The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events., Assessment of the number and type of adverse events, dose-limiting adverse events and serious adverse events following dosing., Baseline to 280 days for subjects participating in Parts 1b and 2a|Vital signs assessment (heart rate), Changes from pre-dose values (beats per minute), Baseline to Day 280|Vital signs assessment (blood pressure), Changes from pre-dose values (mm hg), Baseline to Day 280|Vital signs assessment (oral temperature), Changes from pre-dose values (temperature in celsius degrees), Baseline to Day 280|12-lead ECG assessment (heart rate), Changes from pre-dose values (beats per minute), Baseline to Day 280|12-lead ECG assessment (QT interval), Changes from pre-dose values for QT internal length (msec), Baseline to Day 280|12-lead ECG assessment (QTcF Interval), Changes from pre-dose values for QTcF interval length (msec), Baseline to Day 280|12-lead ECG assessment (PR Interval), Changes from pre-dose values for PR interval length (msec), Baseline to Day 280|12-lead ECG assessment (QRS Duration), Changes from pre-dose values for QRS duration (msec), Baseline to Day 280|Clinical laboratory assessment- Hemoglobin Blood Sample Test, Change from pre-dose value for hemoglobin (gm/dl), Baseline to Day 280|Clinical laboratory assessment- Hematocrit Blood Sample Test, Change from pre-dose value for hematocrit (%), Baseline to Day 280|Clinical laboratory assessment- Packed Cell Volume Blood Sample Test, Change from pre-dose value for packed cell volume (%), Baseline to Day 280|Clinical laboratory assessment- Red Blood Cell Sample Test, Change from pre-dose value for red blood cells (g/dL), Baseline to Day 280|Clinical laboratory assessment- Mean Corpuscular Volume Blood Sample Test, Change from pre-dose value for mean corpuscular volume (fL), Baseline to Day 280|Clinical laboratory assessment- Mean Corpuscular Hemoglobin Blood Sample Test, Change from pre-dose value for mean corpuscular hemoglobin (MCH), Baseline to Day 280|Clinical laboratory assessment- Mean Corpuscular Hemoglobin Concentration Blood Sample Test, Change from pre-dose value for mean corpuscular hemoglobin concentration (g/dL), Baseline to Day 280|Clinical laboratory assessment- Platelet Count Blood Sample Test, Change from pre-dose value for platelets (microL), Baseline to Day 280|Clinical laboratory assessment- White Blood Cell Sample Test, Change from pre-dose value for White blood cells (cells/L), Baseline to Day 280|Clinical laboratory assessment- Neutrophil Blood Sample Test, Change from pre-dose value for Neutrophils (cells/L), Baseline to Day 280|Clinical laboratory assessment- Lymphocyte Blood Sample Test, Change from pre-dose value for Lymphocytes (cells/mcL), Baseline to Day 280|Clinical laboratory assessment- Monocyte Blood Sample Test, Change from pre-dose value for Monocytes (cells/L), Baseline to Day 280|Clinical laboratory assessment- Eosinophil Blood Sample Test, Change from pre-dose value for Eosinophils (%), Baseline to Day 280|Clinical laboratory assessment- Basophil Blood Sample Test, Change from pre-dose value for Basophils (%), Baseline to Day 280|Clinical laboratory assessment- Coagulation Blood Sample Test, Changes from pre-dose value for Prothrombin time (seconds), Baseline to Day 280|Clinical laboratory assessment- Activated Partial Thromboplastin Time Blood Sample Test, Changes from pre-dose values for Activated partial thromboplastin time (seconds), Baseline to Day 280|Clinical laboratory assessment- Fibrinogen Blood Sample Test, Changes from pre-dose value for Fibrinogen (mg/dL), Baseline to Day 280|Clinical laboratory assessment -Sodium Blood Sample Tests, Changes from pre-dose value for Sodium (mEq/L), Baseline to Day 280|Clinical laboratory assessment- Chloride Blood Sample Test, Changes from pre-dose value for Chloride (mmol/L), Baseline to Day 280|Clinical laboratory assessment- Potassium Blood Sample Test, Changes from pre-dose value for Potassium (mEq/L), Baseline to Day 280|Clinical laboratory assessment- Bicarbonate Blood Sample Test, Changes from pre-dose value for Bicarbonate (mEq/L), Baseline to Day 280|Clinical laboratory assessment- Urea Blood Sample Test, Changes from pre-dose value for Urea mmol/L, Baseline to Day 280|Clinical laboratory assessment -Creatinine Blood Sample Test, Changes from pre-dose value for Creatinine (mg/dL), Baseline to Day 280|Clinical laboratory assessment -Bilirubin (total) Blood Sample Test, Changes from pre-dose value for Bilirubin (mg/dL), Baseline to Day 280|Clinical laboratory assessment -Bilirubin (direct) Blood Sample Test, Changes from pre-dose value for Bilirubin, direct only if total bilirubin is elevated (mg/dL), Baseline to Day 280|Clinical laboratory assessment -Alkaline Phosphatase Blood Sample Test, Changes from pre-dose value for Alkaline Phosphatase (U/L), Baseline to Day 280|Clinical laboratory assessment -Aspartate aminotransferase Blood Sample Test, Changes from pre-dose value for Aspartate aminotransferase (U/L), Baseline to Day 280|Clinical laboratory assessment -Alanine aminotransferase Blood Sample Test, Changes from pre-dose value for Alanine aminotransferase (U/L), Baseline to Day 280|Clinical laboratory assessment -Lactate dehydrogenase Blood Sample Test, Changes from pre-dose value for Lactate dehydrogenase (U/L), Baseline to Day 280|Clinical laboratory assessment -Creatinine Kinase Blood Sample Test, Changes from pre-dose value for Creatine kinase for (U/L), Baseline to Day 280|Clinical laboratory assessment - Gamma glutamyl transferase Blood Sample Test, Changes from pre-dose value for Gamma glutamyl transferase (U/L), Baseline to Day 280|Clinical laboratory assessment - Troponin Blood Sample Test, Changes from pre-dose value for Troponin (ng/mL), Baseline to Day 280|Clinical laboratory assessment - Total Protein Blood Sample Test, Changes from pre-dose value for Total Protein (g/dL), Baseline to Day 280|Clinical laboratory assessment - Albumin Blood Sample Test, Changes from pre-dose value for Albumin (g/dL), Baseline to Day 280|Clinical laboratory assessment - Calcium Blood Sample Test, Changes from pre-dose value for Calcium (mg/dL), Baseline to Day 280|Clinical laboratory assessment - Fasting Glucose Blood Sample Test, Changes from pre-dose value for Fasting Glucose (mg/dL), Baseline to Day 280|Clinical laboratory assessment - Non Fasting Glucose Blood Sample Test, Changes from pre-dose value for Non Fasting Glucose (mg/dL), Baseline to Day 280|Clinical laboratory assessment - Fasting Triglycerides Blood Sample Test, Changes from pre-dose value for Fasting Triglycerides (mg/dL), Baseline to Day 280|Clinical laboratory assessment - Total Fasting Cholesterol Blood Sample Test, Changes from pre-dose value for Total Fasting Cholesterol) (mg/dL), Baseline to Day 280|Clinical laboratory assessment-Bilirubin Urine Sample Test, Changes from pre-dose values for Bilirubin (mg/dL), Baseline to Day 280|Clinical laboratory assessment-Urobilinogen Urine Sample Test, Changes from pre-dose value for Urobilinogen (mmol/L), Baseline to Day 280|Clinical laboratory assessment- Ketones Urine Sample Test, Changes from pre-dose value for Ketones (mmol/L), Baseline to Day 280|Clinical laboratory assessment- Glucose Urine Sample Test, Changes from pre-dose value for Glucose (mmol/L), Baseline to Day 280|Clinical laboratory assessment- Protein Urine Sample Test, Changes from pre-dose values for Protein (mg/dL), Baseline to Day 280|Clinical laboratory assessment- Blood Urine Sample Test, Changes from pre-dose value for Blood (RBC/HPF), Baseline to Day 280|Clinical laboratory assessment- Nitrites Urine Sample Test, Changes from pre-dose value for Nitrites (mg/dL), Baseline to Day 280|Clinical laboratory assessment- pH Urine Sample Test, Changes from pre-dose value for pH (pH value), Baseline to Day 280|Clinical laboratory assessment- Specific Gravity Urine Sample Test, Changes from pre-dose value for Specific Gravity (USG), Baseline to Day 280|Clinical laboratory assessment- Leukocytes Urine Sample Test, Changes from pre-dose value for Leukocytes (leukocytes per microscopic field), Baseline to Day 280
Secondary Outcome Measures: Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf]), Plasma PK Parameter as measured by area under the curve from time 0 extrapolated to infinity \[AUCinf\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Area under the curve to the last measured concentration [AUC0-t]), Plasma PK Parameter as measured by area under the curve from time 0 to the last measured concentration \[AUC0-t\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Area under the curve to 24 hours [AUC0-24]), Plasma PK Parameter as measured by area under the curve from time 0 to 24 hours \[AUC0-24\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax]), Plasma PK Parameter as measured by time to maximum concentration \[Tmax\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Terminal elimination half life [T1/2]), Plasma PK Parameter as measured by terminal elimination half life \[T1/2\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Lag time [Tlag]), Plasma PK Parameter as measured by lag time \[Tlag\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (Volume of distribution [Vz/F]), Plasma PK Parameter as measured by apparent volume of distribution \[Vz/F\], Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (oral clearance [CL/F]), Plasma PK Parameter as measured by oral clearance \[CL/F\] of YCT-529, Pre-dose to 28 days after dosing|Plasma PK Parameter of YCT-529 (maximum concentration [Cmax]), Plasma PK Parameter as measured by maximum concentration \[Cmax\]) of YCT-529, Pre-dose to 28 days after dosing|Pharmacodynamic parameter of YCT-529, including follicle-stimulating hormone, Changes from pre-dose values of follicle-stimulating hormone, Pre-dose to 280 days after dosing|Pharmacodynamic parameter of YCT-529, including luteinizing hormone, Changes from pre-dose values of luteinizing hormone, Pre-dose to 280 days after dosing|Pharmacodynamic parameter of YCT-529, including testosterone, Changes from pre-dose values of testosterone, Pre-dose to 280 days after dosing|Changes in YCT-529 concentrations in semen, Changes in YCT-529 as measured by changes in serum concentrations in semen, Pre-dose to 280 days after dosing