The primary purpose of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Debio 4228.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Administered as IM injection.
Urologic Surgeons of Arizona
Mesa, Arizona, United States
East Valley Urology Center of Arizona
Maximum Plasma Concentration (Cmax) of Debio 4228
Time frame: Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 169; Cohort 3: Predose and at multiple time points post-dose up to Day 169
Area Under the Concentration-time Curve of Debio 4228 Over 12 weeks (AUC84d)
Time frame: Cohorts 1 and 2: Predose and at multiple time points post-dose up to Day 84; Cohort 3: Predose and at multiple time points post-dose up to Day 169
Plasma Concentration of Debio 4228 at Week 12 (C84d)
Time frame: Cohorts 1 and 2: Post-dose on Day 84; Cohort 3: Post-dose on Days 84 and 168
Serum Concentration of Testosterone
Time frame: Cohorts 1 and 2: Predose and at multiple time points post-dose from Days 1 to 85; Cohort 3: Predose and at multiple time points post-dose from Days 1 to 169
Number of Participants who Achieved and Maintained a Testosterone Castration (Testosterone Level of <50 [Nanograms per Deciliter] ng/dL and <20 ng/dL)
Time frame: Cohorts 1, 2, and 3: Days 29 to 85
Number of Participants who Maintained a Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)
Time frame: Cohort 3: Days 29 to 169
Time to Achieve Testosterone Castration (Testosterone Level of <50 ng/dL and <20 ng/dL)
Time frame: Cohorts 1 and 2: Day 1 up to Day 85; Cohort 3: Day 1 up to Day 169
Number of Participants who Experience Local Reactions Categorized as Erythema, Swelling, and Induration at the Injection Site
Time frame: Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Queen Creek, Arizona, United States
Bakersfield Institute of Advanced Urology
Bakersfield, California, United States
Grimaldi Urology
Chula Vista, California, United States
Valley Urology
Fresno, California, United States
Tower Urology,
Los Angeles, California, United States
Alarcon Urology Center
Montebello, California, United States
Urology Center of Southern California
Murrieta, California, United States
Biogenix Molecular
Miami, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
...and 11 more locations
Number of Participants who Experience Pain at Injection Site
Time frame: Cohorts 1 and 2: Immediately, at 2 and 24 hours post-injection on Day 1; Cohort 3: Immediately, at 2 and 24 hours post-injection on Days 1 and 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity
Time frame: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Number of Participants With Related TEAEs, Serious TEAEs, Adverse Events of Special Interest (AESIs), TEAEs Leading to Treatment Delay, and/or Discontinuation, and Death
Time frame: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, and Electrocardiogram (ECG) Parameters
Time frame: Cohorts 1 and 2: Up to Day 169; Cohort 3: Up to Day 197
Percent Change From Baseline in Serum Prostate-Specific Antigen (PSA) Over Time
Time frame: Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169
Change From Baseline of Serum Luteinizing Hormone (LH) Over Time
Time frame: Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169
Change From Baseline in Serum Follicle-Stimulating Hormone (FSH) Over Time
Time frame: Cohorts 1 and 2: Baseline up to Day 85; Cohort 3: Baseline up to Day 169