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| Name | Class |
|---|---|
| Dyna Therapeutics | UNKNOWN |
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Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg |
|
| Group 2 | Experimental | Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg |
|
| Group 3 | Experimental | Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg |
|
| Group 4 | Experimental | Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOL-804-F | Drug | All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period. |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of abiraterone | Area under the plasma drug concentration-time curve from 0 to last | 72 hours |
| Cmax of abiraterone | The maximum or peak concentration between zero and dosing interval | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of abiraterone | Area under the plasma drug concentration-time curve from 0 to infinity | 72 hours |
| Tmax of abiraterone | Time of Maximum Concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Rmax of serum testosterone | The maximum response | 72 hours |
| Imax of serum testosterone | Maximum inhibition | 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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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 |
|---|---|
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Zytiga | Drug | All subjects who have been fasting for at least 10 hours prior to administration will take investigational products orally with water on the administration day of each period. |
|
|
| 72 hours |
| t1/2 of abiraterone | Terminal Half-life | 72 hours |
| CL/F of abiraterone | An estimate of the total body clearance after oral administration | 72 hours |
| Vd/F of abiraterone | Apparent volume of distribution after extravascular administration | 72 hours |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |