Status and phase
Conditions
Treatments
About
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.
Full description
This is a Phase 1b/2a, multicenter, open label, 28-Day repeat-dose escalation study of YCT-529 in healthy men to evaluate the safety, tolerability, PK and PD, and to assess sexual function and mood. Cohorts will be dosed in the fasted or fed state. In the Phase
1b part, 4 dosing cohorts and one optional 5th cohort with 4 participants each will be evaluated. All participants will receive YCT-529. In the Phase 2a part, up to 3 cohorts will receive doses within the range of doses that was well tolerated and had biological activity in the Phase 1b portion. Each Phase 2a cohort will have up to 10 participants.
All participants will receive YCT-529.
The study population in both parts of the study will include healthy men who have decided to have a vasectomy and are waiting for the procedure and men who, in the opinion of the investigator, have made a firm decision not to father children in the future.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participant in good health as confirmed by physical examination, medical history, and clinical laboratory tests.
Participant must provide written informed consent.
Participant must be willing and able to communicate and participate in the whole study.
Participant is 28 to 70 years of age (inclusive) at the time of consent.
Participant has decided to have a vasectomy and is waiting for the procedure or participant, in the opinion of the investigator, has made a firm decision not to father children in the future.
Participant has a body mass index (BMI) 18.0 to 35.0 kg/m2.
Participant has no history of hormonal therapy or 5-alpha reductase inhibitors use in the 90 days prior to the first screening visit.
Participant with partner(s) of childbearing potential agrees to use a method of contraception that is highly effective with any partner (i.e., at a minimum, barrier method plus additional method of contraception) during the study until Day 56 (28 days after the last dose). Condom use is required during the course of the study until Day 56 (28 days after the last dose) to ensure the safety of the participants' sexual partner(s) and avoid potential secondary transmission of study drug. Participant with partner(s) of non-childbearing potential agrees to condom use during the course of the study until Day 56 (28 days after the last dose).
Participant will refrain from donating blood or plasma during the study.
Participant will not use cannabis or any other recreational drugs for at least 30 days before the Screening visit and during the study. The marijuana/cannabis test can be positive at Screening but needs to be negative at admission (Day -1) for a volunteer to be eligible for inclusion in the study.
In the opinion of the investigator, participant is able to adhere to the study requirements, restrictions, schedule of assessments, and requirements related to sperm sample collection and maintenance of the sexual activity diary.
Participant providing at least 2 semen samples during the screening period with sperm parameters within at least the 10th percentile of the WHO range of normality (WHO, 2010):
Exclusion criteria
Men participating in another clinical study involving an investigational drug within the last 30 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 as determined by the PI, except for bilirubin of >20 μmol/L and ALT, AST, GGT and ALP 2-fold above the upper limit of normal. Volunteers with known Gilbert's syndrome will be excluded if total bilirubin is ≥1.5 x ULN.
Evidence of renal impairment at screening
Use of androgens and selective androgen receptor modulators (SARMs) within 90 days before first screening visit.
Volunteers with a body weight < 55 kg.
Systolic blood pressure (BP) >140 mmHg (<45 years) or >160 mmHg (≥45 years) and diastolic BP >90 mmHg at screening and admission.
Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval using Bazett's and Fridericia's QT correction methods in ECG (QTc) interval of >450 msec at screening or predose.
Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease or multiple endocrine deficiencies.
Known history of significant cardiovascular, renal, hepatic (cholecystectomy is not permitted), or prostatic disease. Gilbert's syndrome is allowed (volunteer with known Gilbert's syndrome will be excluded if total bilirubin is ≥1.5 x ULN). If volunteer has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (i.e., direct bilirubin <35% of the total bilirubin).
Current or clinically relevant history of any psychiatric disorder or clinical assessment of significant suicidal risk or risk of self-injury as per the Investigator's judgement.
Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Seasonal allergies (e.g., hay fever) are allowed unless considered clinically significant by the investigator.
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results at screening visit.
Known or suspected alcoholism or drug abuse within the last 2 years that may affect metabolism/transformation of steroid hormones or study treatment compliance.
Volunteers who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening.
Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type.
Current smokers and those who have smoked within at least the last 3 months with a positive urine cotinine test at Screening or admission.
Confirmed positive drugs of abuse test result at Screening and admission and/or positive marijuana/cannabis test at admission (Day -1).
Participants and volunteers who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies/supplements (other than up to 4 g of paracetamol or up to 3.2 g of ibuprofen per day during the 14 days before IMP administration). COVID-19 vaccines are accepted concomitant medications. Other concomitant medications may be accepted at the discretion of both the PI and the Sponsor. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardize the safety of the trial participant; and if the use of medication is not considered to interfere with the objectives of the study.
Male volunteer with pregnant or lactating partner(s).
Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
Any other medical condition that, in the opinion of the investigator, could alter the volunteer's well-being, the study conduct, or the interpretability of the results.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Loading...
Central trial contact
Nadja Mannowetz, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal