NCT06014853

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

August 14, 2023

Last Update Submit

February 2, 2024

Conditions

Prostate Cancer

Keywords

Abiraterone

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • AUCinf of abiraterone

    72 hours

  • Tmax of abiraterone

    72 hours

  • t1/2 of abiraterone

    72 hours

  • CL/F of abiraterone

    72 hours

  • Vd/F of abiraterone

    72 hours

Other Outcomes (2)

  • Rmax of serum testosterone

    72 hours

  • Imax of serum testosterone

    72 hours

Study Arms (4)

Group 1

EXPERIMENTAL

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-FDrug: Zytiga

Group 2

EXPERIMENTAL

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-FDrug: Zytiga

Group 3

EXPERIMENTAL

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-FDrug: Zytiga

Group 4

EXPERIMENTAL

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-FDrug: Zytiga

Interventions

SOL-804-FDRUG

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.

Also known as: SOL-804-F 181.5mg/242.0mg/302.5mg
Group 1Group 2Group 3Group 4
ZytigaDRUG

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.

Also known as: Zytiga 500mg
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • SeungHwan Lee

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 28, 2023

Study Start

August 10, 2023

Primary Completion

October 28, 2023

Study Completion

November 16, 2023

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)