CompletedNCT06014853Updated Feb 5, 2024

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

A Phase 1 interventional study of SOL-804-F and Zytiga in Prostate Cancer, sponsored by Bukwang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Bukwang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 19 Years to 50 Years
Sex: Male

Study summary

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

Read the 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.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,353

Keywords

Abiraterone

Who can participate

Ages eligible: 19 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

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 · Drug: Zytiga
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 · Drug: Zytiga
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 · Drug: Zytiga
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 · Drug: Zytiga

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.
Also known as: SOL-804-F 181.5mg/242.0mg/302.5mg
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.
Also known as: Zytiga 500mg

What researchers measure

Primary outcomes

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

Secondary outcomes

AUCinf of abiraterone
Area under the plasma drug concentration-time curve from 0 to infinity
Time frame: 72 hours
Tmax of abiraterone
Time of Maximum Concentration
Time frame: 72 hours
t1/2 of abiraterone
Terminal Half-life
Time frame: 72 hours
CL/F of abiraterone
An estimate of the total body clearance after oral administration
Time frame: 72 hours
Vd/F of abiraterone
Apparent volume of distribution after extravascular administration
Time frame: 72 hours

Other outcomes

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

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06014853
Lead sponsor: Bukwang Pharmaceutical
Collaborators: Dyna Therapeutics
Responsible party: Sponsor
First posted: Aug 28, 2023
Start date: Aug 10, 2023
Primary completion: Oct 28, 2023
Completion: Nov 16, 2023
Last update: Feb 5, 2024

Study contacts

SeungHwan Lee

principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Prostatic Neoplasms→

Other studies from this sponsor

Bukwang Pharmaceutical

Start the discussion