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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06542237




Registration number
NCT06542237
Ethics application status
Date submitted
3/07/2024
Date registered
7/08/2024
Date last updated
3/10/2024

Titles & IDs
Public title
Open Label, Repeat Dose Study Evaluating YCT-529 in Healthy Males
Scientific title
Open Label Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Daily Oral Dosing of YCT-529 for 28 Days in Healthy Men
Secondary ID [1] 0 0
YCT-529-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Contraception 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YCT-529

Experimental: YCT-529 - Open label, ascending dose, 2 part study (Part 1b and Part 2a)


Treatment: Drugs: YCT-529
In the Phase 1b part of the study, 4 dosing cohorts and one optional 5th cohort with 4 participants will be evaluated (up to 20 participants): 15, 45, 90 and 180 mg. In the Phase 2a part, up to 3 cohorts of up to 10 participants (up to 30 participants) will receive doses within the range of doses that was well tolerated and had biological activity in the Phase 1b portion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Timepoint [1] 0 0
Baseline to 280 days for subjects participating in Parts 1b and 2a
Primary outcome [2] 0 0
Vital signs assessment (heart rate)
Timepoint [2] 0 0
Baseline to Day 280
Primary outcome [3] 0 0
Vital signs assessment (blood pressure)
Timepoint [3] 0 0
Baseline to Day 280
Primary outcome [4] 0 0
Vital signs assessment (oral temperature)
Timepoint [4] 0 0
Baseline to Day 280
Primary outcome [5] 0 0
12-lead ECG assessment (heart rate)
Timepoint [5] 0 0
Baseline to Day 280
Primary outcome [6] 0 0
12-lead ECG assessment (QT interval)
Timepoint [6] 0 0
Baseline to Day 280
Primary outcome [7] 0 0
12-lead ECG assessment (QTcF Interval)
Timepoint [7] 0 0
Baseline to Day 280
Primary outcome [8] 0 0
12-lead ECG assessment (PR Interval)
Timepoint [8] 0 0
Baseline to Day 280
Primary outcome [9] 0 0
12-lead ECG assessment (QRS Duration)
Timepoint [9] 0 0
Baseline to Day 280
Primary outcome [10] 0 0
Clinical laboratory assessment- Hemoglobin Blood Sample Test
Timepoint [10] 0 0
Baseline to Day 280
Primary outcome [11] 0 0
Clinical laboratory assessment- Hematocrit Blood Sample Test
Timepoint [11] 0 0
Baseline to Day 280
Primary outcome [12] 0 0
Clinical laboratory assessment- Packed Cell Volume Blood Sample Test
Timepoint [12] 0 0
Baseline to Day 280
Primary outcome [13] 0 0
Clinical laboratory assessment- Red Blood Cell Sample Test
Timepoint [13] 0 0
Baseline to Day 280
Primary outcome [14] 0 0
Clinical laboratory assessment- Mean Corpuscular Volume Blood Sample Test
Timepoint [14] 0 0
Baseline to Day 280
Primary outcome [15] 0 0
Clinical laboratory assessment- Mean Corpuscular Hemoglobin Blood Sample Test
Timepoint [15] 0 0
Baseline to Day 280
Primary outcome [16] 0 0
Clinical laboratory assessment- Mean Corpuscular Hemoglobin Concentration Blood Sample Test
Timepoint [16] 0 0
Baseline to Day 280
Primary outcome [17] 0 0
Clinical laboratory assessment- Platelet Count Blood Sample Test
Timepoint [17] 0 0
Baseline to Day 280
Primary outcome [18] 0 0
Clinical laboratory assessment- White Blood Cell Sample Test
Timepoint [18] 0 0
Baseline to Day 280
Primary outcome [19] 0 0
Clinical laboratory assessment- Neutrophil Blood Sample Test
Timepoint [19] 0 0
Baseline to Day 280
Primary outcome [20] 0 0
Clinical laboratory assessment- Lymphocyte Blood Sample Test
Timepoint [20] 0 0
Baseline to Day 280
Primary outcome [21] 0 0
Clinical laboratory assessment- Monocyte Blood Sample Test
Timepoint [21] 0 0
Baseline to Day 280
Primary outcome [22] 0 0
Clinical laboratory assessment- Eosinophil Blood Sample Test
Timepoint [22] 0 0
Baseline to Day 280
Primary outcome [23] 0 0
Clinical laboratory assessment- Basophil Blood Sample Test
Timepoint [23] 0 0
Baseline to Day 280
Primary outcome [24] 0 0
Clinical laboratory assessment- Coagulation Blood Sample Test
Timepoint [24] 0 0
Baseline to Day 280
Primary outcome [25] 0 0
Clinical laboratory assessment- Activated Partial Thromboplastin Time Blood Sample Test
Timepoint [25] 0 0
Baseline to Day 280
Primary outcome [26] 0 0
Clinical laboratory assessment- Fibrinogen Blood Sample Test
Timepoint [26] 0 0
Baseline to Day 280
Primary outcome [27] 0 0
Clinical laboratory assessment -Sodium Blood Sample Tests
Timepoint [27] 0 0
Baseline to Day 280
Primary outcome [28] 0 0
Clinical laboratory assessment- Chloride Blood Sample Test
Timepoint [28] 0 0
Baseline to Day 280
Primary outcome [29] 0 0
Clinical laboratory assessment- Potassium Blood Sample Test
Timepoint [29] 0 0
Baseline to Day 280
Primary outcome [30] 0 0
Clinical laboratory assessment- Bicarbonate Blood Sample Test
Timepoint [30] 0 0
Baseline to Day 280
Primary outcome [31] 0 0
Clinical laboratory assessment- Urea Blood Sample Test
Timepoint [31] 0 0
Baseline to Day 280
Primary outcome [32] 0 0
Clinical laboratory assessment -Creatinine Blood Sample Test
Timepoint [32] 0 0
Baseline to Day 280
Primary outcome [33] 0 0
Clinical laboratory assessment -Bilirubin (total) Blood Sample Test
Timepoint [33] 0 0
Baseline to Day 280
Primary outcome [34] 0 0
Clinical laboratory assessment -Bilirubin (direct) Blood Sample Test
Timepoint [34] 0 0
Baseline to Day 280
Primary outcome [35] 0 0
Clinical laboratory assessment -Alkaline Phosphatase Blood Sample Test
Timepoint [35] 0 0
Baseline to Day 280
Primary outcome [36] 0 0
Clinical laboratory assessment -Aspartate aminotransferase Blood Sample Test
Timepoint [36] 0 0
Baseline to Day 280
Primary outcome [37] 0 0
Clinical laboratory assessment -Alanine aminotransferase Blood Sample Test
Timepoint [37] 0 0
Baseline to Day 280
Primary outcome [38] 0 0
Clinical laboratory assessment -Lactate dehydrogenase Blood Sample Test
Timepoint [38] 0 0
Baseline to Day 280
Primary outcome [39] 0 0
Clinical laboratory assessment -Creatinine Kinase Blood Sample Test
Timepoint [39] 0 0
Baseline to Day 280
Primary outcome [40] 0 0
Clinical laboratory assessment - Gamma glutamyl transferase Blood Sample Test
Timepoint [40] 0 0
Baseline to Day 280
Primary outcome [41] 0 0
Clinical laboratory assessment - Troponin Blood Sample Test
Timepoint [41] 0 0
Baseline to Day 280
Primary outcome [42] 0 0
Clinical laboratory assessment - Total Protein Blood Sample Test
Timepoint [42] 0 0
Baseline to Day 280
Primary outcome [43] 0 0
Clinical laboratory assessment - Albumin Blood Sample Test
Timepoint [43] 0 0
Baseline to Day 280
Primary outcome [44] 0 0
Clinical laboratory assessment - Calcium Blood Sample Test
Timepoint [44] 0 0
Baseline to Day 280
Primary outcome [45] 0 0
Clinical laboratory assessment - Fasting Glucose Blood Sample Test
Timepoint [45] 0 0
Baseline to Day 280
Primary outcome [46] 0 0
Clinical laboratory assessment - Non Fasting Glucose Blood Sample Test
Timepoint [46] 0 0
Baseline to Day 280
Primary outcome [47] 0 0
Clinical laboratory assessment - Fasting Triglycerides Blood Sample Test
Timepoint [47] 0 0
Baseline to Day 280
Primary outcome [48] 0 0
Clinical laboratory assessment - Total Fasting Cholesterol Blood Sample Test
Timepoint [48] 0 0
Baseline to Day 280
Primary outcome [49] 0 0
Clinical laboratory assessment-Bilirubin Urine Sample Test
Timepoint [49] 0 0
Baseline to Day 280
Primary outcome [50] 0 0
Clinical laboratory assessment-Urobilinogen Urine Sample Test
Timepoint [50] 0 0
Baseline to Day 280
Primary outcome [51] 0 0
Clinical laboratory assessment- Ketones Urine Sample Test
Timepoint [51] 0 0
Baseline to Day 280
Primary outcome [52] 0 0
Clinical laboratory assessment- Glucose Urine Sample Test
Timepoint [52] 0 0
Baseline to Day 280
Primary outcome [53] 0 0
Clinical laboratory assessment- Protein Urine Sample Test
Timepoint [53] 0 0
Baseline to Day 280
Primary outcome [54] 0 0
Clinical laboratory assessment- Blood Urine Sample Test
Timepoint [54] 0 0
Baseline to Day 280
Primary outcome [55] 0 0
Clinical laboratory assessment- Nitrites Urine Sample Test
Timepoint [55] 0 0
Baseline to Day 280
Primary outcome [56] 0 0
Clinical laboratory assessment- pH Urine Sample Test
Timepoint [56] 0 0
Baseline to Day 280
Primary outcome [57] 0 0
Clinical laboratory assessment- Specific Gravity Urine Sample Test
Timepoint [57] 0 0
Baseline to Day 280
Primary outcome [58] 0 0
Clinical laboratory assessment- Leukocytes Urine Sample Test
Timepoint [58] 0 0
Baseline to Day 280
Secondary outcome [1] 0 0
Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf])
Timepoint [1] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [2] 0 0
Plasma PK Parameter of YCT-529 (Area under the curve to the last measured concentration [AUC0-t])
Timepoint [2] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [3] 0 0
Plasma PK Parameter of YCT-529 (Area under the curve to 24 hours [AUC0-24])
Timepoint [3] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [4] 0 0
Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax])
Timepoint [4] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [5] 0 0
Plasma PK Parameter of YCT-529 (Terminal elimination half life [T1/2])
Timepoint [5] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [6] 0 0
Plasma PK Parameter of YCT-529 (Lag time [Tlag])
Timepoint [6] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [7] 0 0
Plasma PK Parameter of YCT-529 (Volume of distribution [Vz/F])
Timepoint [7] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [8] 0 0
Plasma PK Parameter of YCT-529 (oral clearance [CL/F])
Timepoint [8] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [9] 0 0
Plasma PK Parameter of YCT-529 (maximum concentration [Cmax])
Timepoint [9] 0 0
Pre-dose to 28 days after dosing
Secondary outcome [10] 0 0
Pharmacodynamic parameter of YCT-529, including follicle-stimulating hormone
Timepoint [10] 0 0
Pre-dose to 280 days after dosing
Secondary outcome [11] 0 0
Pharmacodynamic parameter of YCT-529, including luteinizing hormone
Timepoint [11] 0 0
Pre-dose to 280 days after dosing
Secondary outcome [12] 0 0
Pharmacodynamic parameter of YCT-529, including testosterone
Timepoint [12] 0 0
Pre-dose to 280 days after dosing
Secondary outcome [13] 0 0
Changes in YCT-529 concentrations in semen
Timepoint [13] 0 0
Pre-dose to 280 days after dosing

Eligibility
Key inclusion criteria
1. Participant in good health as confirmed by physical examination, medical history, and clinical laboratory tests.
2. Participant must provide written informed consent.
3. Participant must be willing and able to communicate and participate in the whole study.
4. Participant is 28 to 70 years of age (inclusive) at the time of consent.
5. 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.
6. Participant has a body mass index (BMI) 18.0 to 35.0 kg/m2.
7. Participant has no history of hormonal therapy or 5-alpha reductase inhibitors use in the 90 days prior to the first screening visit.
8. 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).
9. Participant will refrain from donating blood or plasma during the study.
10. 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.
11. 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.
12. Participant providing at least 2 semen samples during the screening period with sperm parameters within at least the 5th percentile of the WHO range of normality (WHO, 2010 and WHO 2021):

* 15 million sperm cells/mL
* 39 million sperm cells/total ejaculate
* 40% total motility
* 30% progressive motility
Minimum age
28 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. Clinically significant abnormal physical and/or laboratory findings at Screening
3. 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.
4. Evidence of renal impairment at screening
5. Use of androgens and selective androgen receptor modulators (SARMs) within 90 days before first screening visit.
6. Volunteers with a body weight < 55 kg.
7. Systolic blood pressure (BP) >140 mmHg (<45 years) or >160 mmHg (=45 years) and diastolic BP >90 mmHg at screening and admission.
8. 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.
9. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease or multiple endocrine deficiencies.
10. 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).
11. 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.
12. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
13. 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.
14. 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.
15. Known or suspected alcoholism or drug abuse within the last 2 years that may affect metabolism/transformation of steroid hormones or study treatment compliance.
16. Volunteers who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening.
17. 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.
18. Current smokers who have consumed at least 5 cigarettes or equivalent amount of nicotine per week within the last 3 months prior to Screening.
19. Confirmed positive drugs of abuse test result at Screening and admission and/or positive marijuana/cannabis test at admission (Day -1).
20. 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.
21. Male volunteer with pregnant or lactating partner(s).
22. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
23. 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.

-

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
YourChoice Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06542237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rohit Katia, MBChB
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nadja Mannowetz, PhD
Address 0 0
Country 0 0
Phone 0 0
415-233-6970
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06542237