NCT06014853

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bukwang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	SOL-804-F	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.
DRUG	Zytiga	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.

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-10-28
• Completion: 2023-11-16
• First posted: 2023-08-28
• Last updated: 2024-02-05

Locations

1 site across 1 country: South Korea