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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: SOL-804-F; Drug: Zytiga

• Registration Number: NCT06014853
• Lead Sponsor: Bukwang Pharmaceutical

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.

Study Timeline

• Study Start: 2023-08-10
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Primary Completion: 2023-10-28
• Study Completion: 2023-11-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

1. healthy adult male volunteers between 19 to 50 years of age at screening visit.
2. Body mass index (BMI) between 19.0 to 30.0 kg/m2
3. The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
4. The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)

Exclusion Criteria

1. Clinically significant abnormal physical examination, vital signs or ECG
2. The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
3. The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
4. The subjects who have a history of drug abuse or positive with urine drug screening test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 4	Zytiga	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
Group 3	SOL-804-F	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 2	Zytiga	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 1	Zytiga	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 3	Zytiga	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	SOL-804-F	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
Group 2	SOL-804-F	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 1	SOL-804-F	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

Primary Outcome Measures

Name	Time	Method
AUClast of abiraterone	72 hours	Area under the plasma drug concentration-time curve from 0 to last
Cmax of abiraterone	72 hours	The maximum or peak concentration between zero and dosing interval

Secondary Outcome Measures

Name	Time	Method
Tmax of abiraterone	72 hours	Time of Maximum Concentration
t1/2 of abiraterone	72 hours	Terminal Half-life
AUCinf of abiraterone	72 hours	Area under the plasma drug concentration-time curve from 0 to infinity
Vd/F of abiraterone	72 hours	Apparent volume of distribution after extravascular administration
CL/F of abiraterone	72 hours	An estimate of the total body clearance after oral administration

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of