A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SOL-804 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: SOL-804-F
* Drug: Zytiga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult male volunteers between 19 to 50 years of age at screening visit. Body mass index (BMI) between 19.0 to 30.0 kg/m2 The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.) Exclusion Criteria: Clinically significant abnormal physical examination, vital signs or ECG The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc. The subjects who have a history of drug abuse or positive with urine drug screening test

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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 | Drug: SOL-804-F<br>* 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.<br>* Other names: SOL-804-F 181.5mg/242.0mg/302.5mg;Drug: Zytiga<br>* 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.<br>* Other names: Zytiga 500mg;|
| Experimental: Group 2<br>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 | Drug: SOL-804-F<br>* 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.<br>* Other names: SOL-804-F 181.5mg/242.0mg/302.5mg;Drug: Zytiga<br>* 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.<br>* Other names: Zytiga 500mg;|
| Experimental: Group 3<br>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 | Drug: SOL-804-F<br>* 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.<br>* Other names: SOL-804-F 181.5mg/242.0mg/302.5mg;Drug: Zytiga<br>* 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.<br>* Other names: Zytiga 500mg;|
| Experimental: Group 4<br>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 | Drug: SOL-804-F<br>* 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.<br>* Other names: SOL-804-F 181.5mg/242.0mg/302.5mg;Drug: Zytiga<br>* 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.<br>* Other names: Zytiga 500mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abiraterone