Clinical trial NCT04889651: A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 \[Sequence A (TRTR) \& Sequence B (RTRT), T: BR9004, single oral administration, R: BR9004-1, single oral administration\].

Eligibility criteria: Inclusion Criteria:

1. 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
2. Healthy males aged between 19 and 55 at the time of the screening test
3. Those who weigh over 50 kg with BMI of 18.0 to 30.0 BMI (kg/m2) = Weight(kg) / \[Height(m)\]2

Exclusion Criteria:

1. 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.
2. Those who had clinically significant diseases in the liver, kidneys, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, hematologic, oncologic, and cardiovascular disorders (including orthostatic hypotension), etc.
3. 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)
4. 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
5. Those who showed positive results in HBsAg, hepatitis C virus(HCV) Ab, HIV Ab, and rapid plasma reagin(RPR) test during the screening test
6. 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))
7. 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
8. 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)
9. 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
10. 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)
11. Those who smoked over 10 cigarettes a day within 6 months of the screening
12. 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)
13. 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
14. 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
15. 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.
16. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, etc.
17. Those undergoing combined therapy with radium-223 chloride
18. Those whom the investigator judges unsuitable for participation in this study for other reasons

Primary outcomes:
measure: Pharmacokinetic variables-Cmax
timeFrame: 1~22 days after medication
measure: Pharmacokinetic variables-AUClast
timeFrame: 1~22 days after medication
Secondary outcomes:
measure: Pharmacokinetic variables-t1/2β
timeFrame: 1~22 days after medication
measure: Pharmacokinetic variables-Tmax
timeFrame: 1~22 days after medication
measure: Pharmacokinetic variables-AUCinf
timeFrame: 1~22 days after medication
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Seongnam-si
Study officials:
affiliation: CHA University
name: An-Hye Kim
role: PRINCIPAL_INVESTIGATOR
References: