Benign Prostatic Hyperplasia (BPH)Phase 1NCT04485585
A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
A Phase 1 study testing BR9006-1 and BR9006-2 in people with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers. 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
- Benign Prostatic Hyperplasia (BPH), Overactive Bladder
- What is being tested?
- BR9006-1 and BR9006-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2020to 26 Aug 2020
- 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
- Subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an IRB-approved written consent to participate in the trial.
- Healthy male adults aged 19 to 55 years at screening.
- The subject's weight is 50kg or more and body mass index (BMI) is 18.0 or more but 30.0 or less.
Who cannot join
- Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients (Tamsulosin and Mirabegron) and other ingredients of investigational products, Food Yellow No. 5 (Sunset Yellow FCF) or Sulfonamide.
- Those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc.
- Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
- Those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance.
- Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.
- Those with any of the following results at screening:
Show all 19Show fewer
- AST or ALT > twice the upper limit of normal range
- T. bilirubin > twice the upper limit of normal range
- Estimated glomerular filtration rate (e-GFR) < 60 mL/min/1.73m2 (MDRD method used)
- Those with systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 95 mmHg or < 60 mmHg from vital signs at screening.
- Those who took drugs (prescription drugs, OTC, herbal medicine or nutritional supplements (vitamins, etc.)) 2 weeks before screening. (However, those may participate in the trial if their safety and study results are considered to be unaffected according to the investigator's judgment.)
- Those who have a drug abuse problem (especially centrally acting drugs including sleeping pills, centrally acting pain reliever, opiates or psychoactive drugs) or have a history of drug abuse.
- Those who have a history of continuous alcohol intake exceeding 21 units/week (1unit=10g=12.5mL) within 6 months before screening.
- Those who have smoked more than 10 cigarettes a day within 6 months before screening.
- Those who have participated in other clinical trials and have been administered with other investigational drugs 180 days prior to the estimated administration date of this study's investigational drugs (However, is not applicable if the investigational drugs from other trials are not administered).
- Those who have given whole blood 8 weeks before screening, who have given plasma/platelet 4 weeks before screening or who have not expressed their consent for blood-donation prohibition between the period from the first administration and 30 days after the final administration of the investigational drugs.
- Those who have not expressed their consent for diet restrictions (grapefruit, caffeine in particular) that can influence absorption, distribution, metabolism and excretion of investigational drugs in the period between 3 days before the first administration and the last visit.
- Those who have not expressed their consent for using contraceptive measures (for example: contraceptive administration and implant or intrauterine devices, sterilization (vasectomy, tubal ligation, etc.)) and barrier methods (combined use of spermicides and condom, contraceptive vaginal diaphragm, contraceptive sponge or cervical cap) that are allowed for clinical trials in the period between the first administration of the investigational drugs and the last visit.
- Others who are judged to be ineligible to participate in the trial by the investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13520
About this study
Official title: An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.
Read the detailed description
A total of 36 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (T, M, T+M) assigned to one sequence group in Period 1, Period 2, and Period 3.
- Being tested
- BR9006-1, BR9006-2
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR9006-1Drug
Also called Tamsulosin HCL
- Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose
BR9006-2Drug
Also called Mirabegron
- Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose
- Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose
| Study group | Role | What they receive |
|---|---|---|
| Sequence T/M/T+M | Experimental | A total of 36 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(T, M, T+M) assigned to on sequence group in Period 1, Period 2, and Period 3.
* Period 1(T): BR9006-1 (Tamsulosin HCL 0.2mg) - 1 capsule QD, five-day repeated-dose
* Period 2(M): BR9006-2 (Mirabegron 50mg) - 1 tablet QD, eleven-day repeated-dose
* Period 3(T+M): BR9006-1 (Tamsulosin HCL 0.2mg) 1 capsule + BR9006-2 (Mirabegron 50mg) 1 tablet QD, five-day repeated-dose
* Washout period between Period 1 and Period 2: five days
* Washout period between Period 2 and Period 3: none Receives: Drug: BR9006-1; Drug: BR9006-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Measured: 0~26 days after medication
Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Measured: 0~26 days after medication
Secondary outcomes (2)
Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Measured: 0~26 days after medication
Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Measured: 0~26 days after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Jul 2020
- Primary completion16 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- An-Hye Kim, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485585
- Sponsor's protocol ID
- BR-TMC-CT-101
- Status last verified
- Oct 2020
- First submitted
- 21 Jul 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT04485585
- Acronym / sponsor ID
- BR-TMC-CT-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 24 Jul 2020 (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.
To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.
Detailed description
A total of 36 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (T, M, T+M) assigned to one sequence group in Period 1, Period 2, and Period 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequence T/M/T+M | Experimental | Drug: BR9006-1, Drug: BR9006-2A total of 36 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(T, M, T+M) assigned to on sequence group in Period 1, Period 2, and Period 3. * Period 1(T): BR9006-1 (Tamsulosin HCL 0.2mg) - 1 capsule QD, five-day repeated-dose * Period 2(M): BR9006-2 (Mirabegron 50mg) - 1 tablet QD, eleven-day repeated-dose * Period 3(T+M): BR9006-1 (Tamsulosin HCL 0.2mg) 1 capsule + BR9006-2 (Mirabegron 50mg) 1 tablet QD, five-day repeated-dose * Washout period between Period 1 and Period 2: five days * Washout period between Period 2 and Period 3: none |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an IRB-approved written consent to participate in the trial.
- Healthy male adults aged 19 to 55 years at screening.
- The subject's weight is 50kg or more and body mass index (BMI) is 18.0 or more but 30.0 or less.
Key exclusion criteria (19 listed)
- Those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients (Tamsulosin and Mirabegron) and other ingredients of investigational products, Food Yellow No. 5 (Sunset Yellow FCF) or Sulfonamide.
- Those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc.
- Those who have medical history of gastrointestinal system diseases (for example: Crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (However, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.)
- Those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance.
- Those who are positive to HBsAg, HCV Ab, HIV Ab, VDRL tests at screening.
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 |
|---|---|---|
| BR9006-1Also: Tamsulosin HCL* Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose | Drug | Sequence T/M/T+M |
| BR9006-2Also: Mirabegron* Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose * Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose | Drug | Sequence T/M/T+M |
Primary outcome
Pharmacokinetic variables - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
Pharmacokinetic variables - Area under the plasma concentration-time curve from time zero to time t(AUCt) of Part A and B
Time frame: 0~26 days after medication
The analysis to investigate drug-drug interaction shall be divided into two parts: Part A (Tamsulosin vs. Tamsulosin + Mirabegron) and Part B (Mirabegron vs. Mirabegron + Tamsulosin).
2 secondary outcomes
Pharmacokinetic variables - Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) of Part A and B
Time frame: 0~26 days after medication
Pharmacokinetic variables - Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss) of Part A and B
Time frame: 0~26 days after medication
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 28 Oct 2020.
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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.
An-Hye Kim principal investigator
CHA University
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 BR9006-1 and BR9006-2 in people with Benign Prostatic Hyperplasia (BPH) and Overactive Bladder, 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 19 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 28 Oct 2020. 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 - Maximum (peak) steady-state plasma drug concentration during a dosage interval(Cmax,ss) of Part A and B (time frame: 0~26 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?
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 28 Oct 2020.