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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06014853

Enrollment

Registered

2023-08-28

Start date

2023-08-10

Completion date

2023-11-16

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Abiraterone

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.

Interventions

DRUGSOL-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.

DRUGZytiga

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Tmax of abiraterone	72 hours	Time of Maximum Concentration
CL/F of abiraterone	72 hours	An estimate of the total body clearance after oral administration
Vd/F of abiraterone	72 hours	Apparent volume of distribution after extravascular administration
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

Other

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026