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

NCT04889651 | Completed Phase 1

• 1 other identifier: BR-ABT-CT-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic variables-Cmax

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

  1~22 days after medication

• 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

  1~22 days after medication

Secondary Outcomes (3)

• Pharmacokinetic variables-t1/2β

  1~22 days after medication

• Pharmacokinetic variables-Tmax

  1~22 days after medication

• Pharmacokinetic variables-AUCinf

  1~22 days after medication

Study Arms (2)

A(TRTR)

EXPERIMENTAL

The 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

Drug: BR9004; Drug: BR9004-1

B(RTRT)

EXPERIMENTAL

The 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

Drug: BR9004; Drug: BR9004-1

Interventions

BR9004 DRUG

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

Also known as: Abiraterone acetate 200mg

A(TRTR); B(RTRT)

BR9004-1 DRUG

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

Also known as: Zytiga Tab

A(TRTR); B(RTRT)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

CHA Bundang Medical Center, CHA University

Gyeonggi-do, Seongnam-si, 13520, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• An-Hye Kim

  CHA University

  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: May 12, 2021
• First Posted: May 17, 2021
• Study Start: April 15, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 22, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-05

Locations

KR (1)