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Completed

NCT Number: NCT06014853

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adult male volunteers between 19 to 50 years of age at screening visit.
  • Body mass index (BMI) between 19.0 to 30.0 kg/m2
  • The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
  • The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)

Exclusion criteria

  • Clinically significant abnormal physical examination, vital signs or ECG
  • The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
  • The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
  • The subjects who have a history of drug abuse or positive with urine drug screening test

Treatment and study plan

SOL-804-F

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.

Other names: SOL-804-F 181.5mg/242.0mg/302.5mg

Zytiga

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.

Other names: Zytiga 500mg

Primary outcomes

  1. AUClast of abiraterone

    Time frame: 72 hours

    Area under the plasma drug concentration-time curve from 0 to last

  2. Cmax of abiraterone

    Time frame: 72 hours

    The maximum or peak concentration between zero and dosing interval

Secondary outcomes

  1. AUCinf of abiraterone

    Time frame: 72 hours

    Area under the plasma drug concentration-time curve from 0 to infinity

  2. Tmax of abiraterone

    Time frame: 72 hours

    Time of Maximum Concentration

  3. t1/2 of abiraterone

    Time frame: 72 hours

    Terminal Half-life

  4. CL/F of abiraterone

    Time frame: 72 hours

    An estimate of the total body clearance after oral administration

  5. Vd/F of abiraterone

    Time frame: 72 hours

    Apparent volume of distribution after extravascular administration

Other outcomes

  1. Rmax of serum testosterone

    Time frame: 72 hours

    The maximum response

  2. Imax of serum testosterone

    Time frame: 72 hours

    Maximum inhibition

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Collaborators

  • Dyna Therapeutics

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2023
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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