Prostate Cancer
Conditions
Brief summary
This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.
Detailed description
The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.
Interventions
DRUGHRS-5041 dose level 1
Single dose of HRS-5041 orally administered
DRUGHRS-5041 dose level 2
Single dose of HRS-5041 orally administered
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Caucasian participants; 2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial, 3. Male aged between 18 to 55 years of age (inclusive) at the date of signed consent form. 4. Total body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening.
Exclusion criteria
1. History of receiving any androgen receptor (AR) degraders. 2. History or evidence of clinically significant 3. History of severe abnormal gastric emptying, severe gastrointestinal (GI) disease, or participants who had GI surgeries (except GI polypectomy). 4. Severe infections, injuries, or major surgeries as determined by the investigator within 6 months 5. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter: Vz/F |
| PK profile (Cmax) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameters: Cmax |
| PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter: AUC0-t |
| PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter:AUC0-inf |
| PK profile (Tmax) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter: Tmax |
| PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter: t1/2 |
| PK profile (CL/F) of HRS-5041 after a single oral (PO) administration: | Day 10 | Parameter: CL/F |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability - Blood pressure | Day 10 | Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure) |
| Safety and tolerability - Body temperature | Day 10 | Incidence of Adverse Events and Abnormalities as assessed by body temperature |
| Safety and tolerability - Physical examination | Day 10 | Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination |
| Safety and tolerability - Laboratory tests | Day 10 | Number of abnormalities assessed based on safety bloods and urine test |
| Safety and tolerability - ECG | Day 10 | heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS |
| Safety and tolerability - number and severity of adverse events | Day 10 | Incidence and severity of AE |
Countries
Australia
Outcome results
None listed