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Prostate CancerPhase 1NCT04889651

A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers

A Phase 1 study testing BR9004 and BR9004-1 in people with Prostate Cancer, run by Boryung Pharmaceutical Co., Ltd 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

To compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects after a single-dose administration while fasting. Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
BR9004 and BR9004-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
15 Apr 2021to 22 Jun 2021
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Those who voluntarily signed the Institutional Review Board(IRB)-approved informed consent to participate in this study after being given an sufficient explanation about the study objectives, details, and characteristics of the investigational product
  • Healthy males aged between 19 and 55 at the time of the screening test
  • Those who weigh over 50 kg with BMI of 18.0 to 30.0 BMI (kg/m2) = Weight(kg) / [Height(m)]2

Who cannot join

  • Those who had a clinically significant medical history such as hypersensitivity reaction, intolerance, and anaphylaxis against Abiraterone which is the main ingredient of the investigational products.
  • Those who had clinically significant diseases in the liver, kidneys, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, hematologic, oncologic, and cardiovascular disorders (including orthostatic hypotension), etc.
  • Those who had gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, etc.) that may affect the absorption of the investigational products or underwent surgeries (excluding appendectomy, hernia surgery, endoscopic removal of polys, and surgeries for piles, anal fissure, anal fistula)
  • Those who were judged to have clinically significant abnormal results in the interview, vital signs, ECG, physical examinations, blood \& urine test, etc. during the screening test
  • Those who showed positive results in HBsAg, hepatitis C virus(HCV) Ab, HIV Ab, and rapid plasma reagin(RPR) test during the screening test
  • Those who showed one of the following results during the screening test:
Show all 22Show fewer
  • Aspartate aminotransferase(AST) or Alanine aminotransferase(ALT) higher than 2 times the upper limit of normal range
  • T. bilirubin higher than 2 times than the upper limit of normal range
  • Estimated Glomerular Filtration Rate(e-GFR) lower than 60 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI))
  • Those who showed > 150 mmHg or < 90 mmHg of systolic blood pressure or > 95 mmHg or < 60 mmHg of diastolic blood pressure during the screening test
  • Those who did not agree to stop taking prohibited drugs (prescription drugs, over-the-counter drugs, herbal medicines or nutritional supplements, e.g., vitamins) within 2 weeks after the administration of investigational products (accepted if the investigator judges that the drug may not affect the safety of the subject and study results)
  • Those who had drug abuse (especially drugs that affect the central nervous system such as sleeping pills, analgesics that work on the central nervous system(CNS), narcotic drugs, or psychoactive drugs) or have a history of drug abuse
  • Those who had a continuous intake of alcohol that exceeds 21 units/week (1 unit=10g=12.5mL) within 6 months of the screening
  • ☞ Amount of alcohol(g) = Amount of intake (ml) x Alcohol degree (%) x 0.8 (10g=12.5mL)
  • Those who smoked over 10 cigarettes a day within 6 months of the screening
  • Those administered with the investigational products by participating in other clinical studies within 180 days before the first administration of the investigational products (however, the day after the last administration date is considered Day 1 after the previous study participation ends)
  • Those who donated whole blood within 8 weeks and plasma or platelet within 4 weeks before the first administration of the investigational products or who did not agree to stop donating blood donation for 30 days from the date when the investigational products are administered
  • Those who did not agree to stop having foods diets (especially those containing grape fruit-containing foods) that may affect the absorption, distribution, metabolism, and excretion of the investigational products from 3 days before the first administration until the last visit
  • Those who did not agree to use clinically accepted contraceptive methods (e.g., contraceptive pills, intrauterine devices, sterilization procedures(vasectomy, and tubal ligation) or barrier methods (combined use of spermicide and condom, contraceptive diaphragm, vaginal sponge or cervical cap)) for at least 3 weeks after the last administration from the first administration of investigational products.
  • Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, etc.
  • Those undergoing combined therapy with radium-223 chloride
  • Those whom the investigator judges unsuitable for participation in this study for other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, Seongnam-si, 13520

Other trials in South Korea

About this study

Official title: A Randomized, Open Label, Single Dose, Full Replicated Crossover Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers

To compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects after a single-dose administration while fasting.

Read the detailed description

This is a randomized, open label, single dose, full replicated crossover study to compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects under fasting conditions. To this end, subjects were divided into two sequence groups [Sequence A (TRTR) \& Sequence B (RTRT), T: BR9004, single oral administration, R: BR9004-1, single oral administration].

Conditions
Prostate Cancer
Being tested
BR9004, BR9004-1
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • BR9004Drug

    Also called Abiraterone acetate 200mg

    BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.

  • BR9004-1Drug

    Also called Zytiga Tab

    BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea

Study groups in NCT04889651
Study groupRoleWhat they receive
A(TRTR)ExperimentalThe selected subjects are randomized into two sequence group(Sequence A (TRTR) \& Sequence B (RTRT)). * Sequence A: T-R-T-R * T: BR9004, oral single-dose administration, 1 tablet per day * R: BR9004-1, oral single-dose administration, 1 tablet per day * Washout interval between periods: 7 days
Receives: Drug: BR9004; Drug: BR9004-1
B(RTRT)ExperimentalThe selected subjects are randomized into two sequence group(Sequence A (TRTR) \& Sequence B (RTRT)). * Sequence B: R-T-R-T * T: BR9004, oral single-dose administration, 1 tablet per day * R: BR9004-1, oral single-dose administration, 1 tablet per day * Washout interval between periods: 7 days
Receives: Drug: BR9004; Drug: BR9004-1

What is being measured

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

  1. Pharmacokinetic variables-Cmax

    Maximum observed plasma concentration(Cmax) of BR9004 and BR9004-1

    Measured: 1~22 days after medication

  2. Pharmacokinetic variables-AUClast

    Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration(AUClast) of BR9004 and BR9004-1

    Measured: 1~22 days after medication

Secondary outcomes (3)

  1. Pharmacokinetic variables-t1/2β

    Terminal half-life(t1/2β) of BR9004 and BR9004-1

    Measured: 1~22 days after medication

  2. Pharmacokinetic variables-Tmax

    Time of maximum concentration(Tmax) of BR9004 and BR9004-1

    Measured: 1~22 days after medication

  3. Pharmacokinetic variables-AUCinf

    Area under the plasma drug concentration-time curve over the time interval from 0 to extrapolated to infinity(AUCinf) of BR9004 and BR9004-1

    Measured: 1~22 days after medication

Timeline

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

  1. First posted17 May 2021
  2. Study start15 Apr 2021
  3. Primary completion8 Jun 2021
  4. Study completion22 Jun 2021

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04889651
Sponsor's protocol ID
BR-ABT-CT-101
Status last verified
May 2021
First submitted
12 May 2021
Last updated
22 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR9004 and BR9004-1 in people with Prostate Cancer, run by Boryung Pharmaceutical Co., Ltd 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 3 inclusion and 22 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 22 Jul 2021. 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?

Pharmacokinetic variables-Cmax (time frame: 1~22 days after medication). 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 NCT04889651.

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 22 Jul 2021.

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