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First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males | Clinical Trials | Clareo Health

COMPLETEDPHASE1

First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males

Double-blind, Placebo Controlled, First in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of YCT-529

NCT06094283•YourChoice Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects.

Detailed Description

This is a Phase 1a, double-blind, placebo controlled, first in human study to evaluate the safety, tolerability, PK, and PD of YCT-529 in 2 cohorts of 8 subjects. Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.

Eligibility

Age

25 - 60 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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.
•2. Subject must provide written informed consent.
•3. Subject must be willing and able to communicate and participate in the whole study.
•4. Subject is 25 to 60 years of age (inclusive).
•5. Subject has been vasectomized for at least 6 months prior to enrolment
•6. Subject has body mass index (BMI) 18.0 to 32.0 kg/m2.
•7. Subject has no history of hormonal therapy uses in the 90 days prior to the first screening visit.
•8. 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)
•9. Subjects will refrain from donating blood or plasma during the study.
•10. Subjects will not use cannabis or any recreational drugs for at least 120 days before completing Screening and during the study.
+1 more criteria

Exclusion Criteria

•1. 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.
•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, such as bilirubin of \>20 micro mol/L and ALT, AST, GGT and ALP above the upper limit of normal.
•4. 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.
•5. Use of androgens within 90 days before first screening visit.
•6. Ongoing use of body building nutritional supplements.
•7. Systolic blood pressure (BP) \>140 mmHg (\<45 years) or \>160 mmHg (≥45 years) and diastolic BP \>90 mmHg at screening or predose.
•8. Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval 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 or significant psychiatric illness. Gilbert's syndrome is allowed (subject will be excluded if total bilirubin is ≥1.5 x ULN if known Gilbert's syndrome). If subject 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).
+15 more criteria

Locations (1)

Quotient Sciences

Nottingham, East Midlands, United Kingdom

Key Dates

Start Date

December 20, 2023

Primary Completion Date

June 18, 2024

Completion Date

June 18, 2024

Last Updated

October 2, 2024

Enrollment

ACTUAL participants

Conditions

Male Contraception

Interventions

YCT-529

DRUG

YCT-529 Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males

Inclusion Criteria

Exclusion Criteria

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Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

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