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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: HRS-5041 dose level 1 | Experimental | Sing dose level 1 |
|
| Experimental: HRS-5041 dose level 2 | Experimental | Sing dose level 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5041 dose level 1 | Drug | Single dose of HRS-5041 orally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK profile (Cmax) of HRS-5041 after a single oral (PO) administration: | Parameters: Cmax | Day 10 |
| PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration: | Parameter: AUC0-t | Day 10 |
| PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration: | Parameter:AUC0-inf | Day 10 |
| PK profile (Tmax) of HRS-5041 after a single oral (PO) administration: | Parameter: Tmax | Day 10 |
| PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration: | Parameter: t1/2 | Day 10 |
| PK profile (CL/F) of HRS-5041 after a single oral (PO) administration: | Parameter: CL/F | Day 10 |
| PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration: | Parameter: Vz/F | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability - number and severity of adverse events | Incidence and severity of AE | Day 10 |
| Safety and tolerability - Blood pressure | Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Melbourne | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000284 | Administration, Oral |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| HRS-5041 dose level 2 | Drug | Single dose of HRS-5041 orally administered |
|
|
| Day 10 |
| Safety and tolerability - Body temperature | Incidence of Adverse Events and Abnormalities as assessed by body temperature | Day 10 |
| Safety and tolerability - Physical examination | Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination | Day 10 |
| Safety and tolerability - Laboratory tests | Number of abnormalities assessed based on safety bloods and urine test | Day 10 |
| Safety and tolerability - ECG | heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS | Day 10 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |