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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: SOL-804-F; Drug: Zytiga

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: SOL-804-F 181.5mg/242.0mg/302.5mg; 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.; Other Names: Zytiga 500mg
Experimental: 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	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.; Other Names: SOL-804-F 181.5mg/242.0mg/302.5mg; 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.; Other Names: Zytiga 500mg
Experimental: 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	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.; Other Names: SOL-804-F 181.5mg/242.0mg/302.5mg; 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.; Other Names: Zytiga 500mg
Experimental: 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	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.; Other Names: SOL-804-F 181.5mg/242.0mg/302.5mg; 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.; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rmax of serum testosterone	The maximum response	72 hours
Imax of serum testosterone	Maximum inhibition	72 hours

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Collaborators: Dyna Therapeutics
• Investigators: Principal Investigator: SeungHwan Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): October 28, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Abiraterone
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Abiraterone Acetate
• Other Study ID Numbers: DN-SOL-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No