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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06014853
• Other study ID #: DN-SOL-102
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2023
• Est. completion date: November 16, 2023

Study information

• Verified date: February 2024
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 16, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical	Dyna Therapeutics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rmax of serum testosterone	The maximum response	72 hours
Other	Imax of serum testosterone	Maximum inhibition	72 hours
Primary	AUClast of abiraterone	Area under the plasma drug concentration-time curve from 0 to last	72 hours
Primary	Cmax of abiraterone	The maximum or peak concentration between zero and dosing interval	72 hours
Secondary	AUCinf of abiraterone	Area under the plasma drug concentration-time curve from 0 to infinity	72 hours
Secondary	Tmax of abiraterone	Time of Maximum Concentration	72 hours
Secondary	t1/2 of abiraterone	Terminal Half-life	72 hours
Secondary	CL/F of abiraterone	An estimate of the total body clearance after oral administration	72 hours
Secondary	Vd/F of abiraterone	Apparent volume of distribution after extravascular administration	72 hours