Prostate CancerPhase 1NCT06014853

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

A Phase 1 study testing SOL-804-F and Zytiga in people with Prostate Cancer, run by Bukwang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostate Cancer
What is being tested?: SOL-804-F and Zytiga
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Korea
Study dates: 10 Aug 2023to 16 Nov 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 03080

Other trials in South Korea

About this study

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

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: Prostate Cancer
Being tested: SOL-804-F, Zytiga
Keywords: Abiraterone
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOL-804-FDrug
Also called SOL-804-F 181.5mg/242.0mg/302.5mg
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.
ZytigaDrug
Also called Zytiga 500mg
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 groups in NCT06014853
Study group	Role	What they receive
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 Receives: Drug: SOL-804-F; Drug: 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 Receives: Drug: SOL-804-F; Drug: 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 Receives: Drug: SOL-804-F; Drug: 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 Receives: Drug: SOL-804-F; Drug: Zytiga

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202316 Nov 2023

First posted28 Aug 2023
Study start10 Aug 2023
Primary completion28 Oct 2023
Study completion16 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06014853
Sponsor's protocol ID: DN-SOL-102
Status last verified: Feb 2024
First submitted: 14 Aug 2023
Last updated: 5 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06014853
Acronym / sponsor ID: DN-SOL-102
Conditions: Prostate Cancer
Keywords: Abiraterone
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
Collaborators: Dyna Therapeutics
Study start: 10 Aug 2023 (actual)
Primary completion: 28 Oct 2023 (actual)
Study completion: 16 Nov 2023 (actual)
First posted: 28 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: SOL-804-F, Drug: ZytigaPeriod 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
Group 2	Experimental	Drug: SOL-804-F, Drug: ZytigaPeriod 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
Group 3	Experimental	Drug: SOL-804-F, Drug: ZytigaPeriod 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
Group 4	Experimental	Drug: SOL-804-F, Drug: ZytigaPeriod 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOL-804-FAlso: SOL-804-F 181.5mg/242.0mg/302.5mgAll 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.	Drug	Group 1, Group 2, Group 3, Group 4
ZytigaAlso: Zytiga 500mgAll 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.	Drug	Group 1, Group 2, Group 3, Group 4

Primary outcome

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

5 secondary outcomes

AUCinf of abiraterone
Time frame: 72 hours
Tmax of abiraterone
Time frame: 72 hours
t1/2 of abiraterone
Time frame: 72 hours
CL/F of abiraterone
Time frame: 72 hours
Vd/F of abiraterone
Time frame: 72 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SeungHwan Lee principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SOL-804-F and Zytiga in people with Prostate Cancer, run by Bukwang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUClast of abiraterone (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.