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Dementia AlzheimersEarly Phase 1NCT04462029

A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers

A Early Phase 1 study testing BR4002 and BR4002-1 in people with Dementia Alzheimers, 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

This study is designed as a randomized, open-label, single-dose, 6x3 crossover study. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Dementia Alzheimers
What is being tested?
BR4002 and BR4002-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSouth Korea
Study dates
5 Jun 2020to 7 Oct 2020
Phase
Early 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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged ≥ 19 and ≤ 55 years at screening
  • Body weight of ≥ 50 kg with calculated body mass index (BMI) of ≥ 18.0 to ≤ 29.0 kg/m2
  • Determined eligible based on the results of physical examination and investigator questioning conducted according to this protocol. That is, absence of congenital or chronic disease, and absence of pathological symptoms or findings based on medical examination in the last 3 years.
  • Determined eligible based on the results of the laboratory tests and electrocardiogram (ECG) conducted according to this protocol
  • Voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a detailed explanation on this study and fully understanding the information

Who cannot join

  • Hypersensitivity to, or history of clinically significant hypersensitivity to donepezil hydrochloride, piperidine derivatives or any ingredients of piperidine derivatives, or other drugs (aspirin, antibiotics, etc.)
  • Hereditary disorders including galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption
  • History of heart disease such as sinus node syndrome, intra-atrial conduction disturbance or atrioventricular junctional conduction disturbance
  • Ongoing administration of non-steroidal anti-inflammatory drugs or history of peptic ulcer
  • History of asthma or obstructive pulmonary disease
  • Extrapyramidal disorder
Show all 26Show fewer
  • Psychotic disorders or drug addiction
  • Presence or prior history of a gastrointestinal disorder or prior history of gastrointestinal surgery or skin graft that may affect the absorption of the IP
  • Presence or prior history of clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematological and oncological, psychotic, or urinary disease
  • Clinically significant hypotension (systolic blood pressure < 90 mmHg) or hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg) at screening
  • Any of the following results from screening tests:
  • AST or ALT > 2 times the upper limit of normal
  • Total bilirubin > 2.0 mg/dL
  • Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
  • QTc > 450 ms or any clinically significant abnormal finding from an ECG result at screening
  • Continuous alcohol intake or inability to stop drinking during the study period
  • Continuous smoking or inability to stop smoking throughout the hospitalization during the study period
  • Participated in another clinical study or bioequivalence study within 6 months prior to the first administration of the IP
  • Donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration of the IP
  • Used any prescription drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs within 7 days prior to the first administration of the IP
  • Used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbitals, within 1 month prior to initiation of the study
  • Have been on a diet (especially grapefruit juice or its product) which may affect absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first administration of the IP
  • Do not agree to exclude the possibility of pregnancy by using medically acceptable methods of contraception from the first day of administration of the IP up to 7 days after the last day of administration of the IP
  • Unwillingness or inability to comply with the diet and lifestyle guidelines required for the study
  • Clinically significant abnormal laboratory results or considered ineligible for study participation by the investigator for any other reason
  • Women who are pregnant, have a positive serum/urine hCG test, or are breastfeeding

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inha University Hospital

    Incheon

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability of BR4002 Comparing to BR4002-1 in Healthy Volunteers

This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.

Read the detailed description

A total of 18 subjects will be randomized into 6 sequence groups. The investigational products will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated.

Being tested
BR4002, BR4002-1
Medical subject headings
Alzheimer Disease

What participants receive

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

  • BR4002Drug

    • Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours
    • Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours

  • BR4002-1Drug

    Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water

Study groups in NCT04462029
Study groupRoleWhat they receive
sequence 1OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 1: R - T1 - T2
Receives: Drug: BR4002; Drug: BR4002-1
sequence 2OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 2: R - T2 - T1
Receives: Drug: BR4002; Drug: BR4002-1
sequence 3OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 3: T1 - R - T2
Receives: Drug: BR4002; Drug: BR4002-1
sequence 4OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 4: T1 - T2 - R
Receives: Drug: BR4002; Drug: BR4002-1
sequence 5OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 5: T2 - R - T1
Receives: Drug: BR4002; Drug: BR4002-1
sequence 6OtherA total of 18 subjects will be randomized into 6 sequence groups. The investigational products (IPs) will be administered according to the treatment groups (R, T1, and T2) assigned to each sequence group in Period 1, Period 2, and Period 3. In between each period, there will be a washout period (28 days) long enough for the administered IP to be metabolized and eliminated. * R(Reference): BR4002-1 (oral intake) 5mg single-dose * T1(Test1): BR4002 (patch) 5mg single-dose (using the applicator) * T2(Test2): BR4002 (patch) 5mg single-dose (not using the applicator) sequence 6: T2 - T1 - R
Receives: Drug: BR4002; Drug: BR4002-1

What is being measured

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

  1. Pharmacokinetic variables -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1

    PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.

    Measured: 0~240 hours after medication

  2. Pharmacokinetic variables - maximum observed plasma concentration(Cmax) of BR4002 and BR4002-1

    PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.

    Measured: 0~240 hours after medication

Secondary outcomes (2)

  1. Pharmacokinetic variables - Area Under the concentration-time Curve from time 0 to infinite after single dosing(AUCinf) of BR4002 and BR4002-1

    PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.

    Measured: 0~240 hours after medication

  2. Pharmacokinetic variables - Time of occurrence of Cmax(Tmax) of BR4002 and BR4002-1

    PK data of subjects who complete all of the scheduled blood collections without any major protocol deviations considered to affect the PK results after administration of the IP and have quantifiable drug concentrations for PK assessment will be analyzed.

    Measured: 0~240 hours 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 posted8 Jul 2020
  2. Study start5 Jun 2020
  3. Primary completion7 Oct 2020
  4. Study completion7 Oct 2020

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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462029
Sponsor's protocol ID
BR-DPZ-CT-102
Status last verified
Oct 2020
First submitted
1 Jul 2020
Last updated
28 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing BR4002 and BR4002-1 in people with Dementia Alzheimers, 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 5 inclusion and 26 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 -Area Under the concentration-time Curve from time 0 to t after single dosing(AUCt) of BR4002 and BR4002-1 (time frame: 0~240 hours 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 NCT04462029.

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.

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