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

NCT ID: NCT06014853

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2023-11-16

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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 Type: EXPERIMENTAL

SOL-804-F

Intervention Type: 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.

Zytiga

Intervention Type: 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.

Group 2

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 Type: EXPERIMENTAL

SOL-804-F

Intervention Type: 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.

Zytiga

Intervention Type: 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.

Group 3

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 Type: EXPERIMENTAL

SOL-804-F

Intervention Type: 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.

Zytiga

Intervention Type: 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.

Group 4

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 Type: EXPERIMENTAL

SOL-804-F

Intervention Type: 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.

Zytiga

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

SOL-804-F 181.5mg/242.0mg/302.5mg; Zytiga 500mg

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dyna Therapeutics

UNKNOWN

Sponsor Role: collaborator

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SeungHwan Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DN-SOL-102

Identifier Type: -

Identifier Source: org_study_id