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Stroke SequelaePhase 1NCT06090474

Multiple Dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability of NDC-002 in Healthy Volunteers

A Phase 1 study testing NDC-002 in people with Stroke Sequelae and Stroke, run by Dr. Noah Biotech Inc. 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

An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability between NDC-002A/NDC-002B and NDC-002C in Healthy Volunteers Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Stroke Sequelae, Stroke
What is being tested?
NDC-002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSouth Korea
Study dates
12 Jan 2023to 15 Mar 2023
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult volunteers aged between 19 and 55 at the time of screening
  • For men, those who weigh 50 kilograms or more and for women, those who weigh 45 kilograms or more and have a body mass index (BMI) between 18.0 and 30.0
  • Those who do not have any congenital or chronic disease and had no pathological symptoms or findings in a medical examination
  • Those who are deemed suitable as subjects by the investigator within four weeks prior to the first administration date of the investigational product based on the characteristics of the drug as a result of interview, physical examination, clinical laboratory test, and electrocardiogram
  • Those who are able to understand and follow instructions and participate throughout the entire clinical trial period
  • Those who agree to contraception use during the clinical trial period and can comply with medically accepted contraceptive methods (including those who are medically infertile)
  • Those who have heard and fully understood a detailed description of this clinical trial and have voluntarily decided to participate in the trial and have agreed in writing to comply with the precautions

Who cannot join

  • Medical History
  • Those with or with a history of clinically significant diseases of the biliary system (biliary obstructive disease, etc.), renal system (severe renal failure, etc.), blood/oncology, cardiovascular system (congestive heart failure, coronary or aortic/mitral stenosis or complications thereof, arrhythmia, renovascular hypertension, etc.), respiratory system (asthma, chronic obstructive pulmonary disease, etc.), liver (moderate or severe liver failure, etc.), endocrine system (diabetes or impaired glucose tolerance, hypothyroidism, primary aldosteronism, etc.), digestive system, musculoskeletal system, or central nervous system disease (Parkinson's disease, etc.), or mental illness or malignant tumor
  • Those with a history of gastrointestinal disease (Crohn's disease, ulcers, gastritis, gastrospasms, gastroesophageal reflux, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect drug absorption
  • Those with a history of hypersensitivity or clinically significant hypersensitivity to donepezil or drugs containing NAC or similar agents (piperidine derivatives, etc.), or other drugs (aspirin, antibiotics, etc.)
  • Those who have suffered from a clinically significant disease within 30 days before the first administration of the investigational product
  • Clinical Laboratory Tests
Show all 28Show fewer
  • Those with systolic blood pressure ≥ 140 mmHg or ≤ 99 mmHg, or diastolic blood pressure ≥ 91 mmHg or ≤ 59 mmHg, or measured pulse rate ≥ 101 or ≤ 40 times per minute for vital signs measured in a sitting position after sufficient rest
  • Those who are tested positive for serological tests (hepatitis B, hepatitis C, syphilis, HIV)
  • Patients with active liver disease, including a persistent increase of liver enzyme levels (AST, ALT) of unknown etiology or an increase of liver enzyme levels ≥ 1.5 times the ULN
  • Patients with renal impairment of moderate or higher renal failure (GFR <60 mL/min based on the Cockcroft-Gault method)
  • Patients with CPK values increased by more than five times the ULN
  • In the case of clinically significant findings on an electrocardiogram or related physical abnormalities or symptoms
  • If the investigator determines that it is difficult to proceed with the trial due to results of physical examinations
  • Allergies and Drug Abuse
  • Those with genetic problems such as intolerance to the additivies for donepezil or NAC
  • Those with a history of drug abuse or who tested positive for drug abuse in the drug screening test
  • Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Contraindicated Concomitant Drugs/Diet
  • Those who have participated in other clinical trials within 180 days before the first administration of the investigational product
  • Those who have taken metabolism-inducing or inhibiting drugs (CYP2D6 or CYP3A4 inducers, inhibitors, etc.) within 28 days before the first administration of the investigational product
  • Those who have taken herbal medicine within 28 days, prescription drugs within 14 days, or over-the-counter drugs within seven days before the first administration of the investigational product (however, if other conditions are reasonable, at the discretion of the investigator, the subject may participate in the clinical trial)
  • Other
  • Those who have done whole blood donation within 60 days, or apheresis within 28 days before the first administration of the investigational product, or received a blood transfusion within 28 days before the first administration
  • Those who have consumed excessive alcohol within 28 days before the first administration (alcohol > 30 g/day; soju > 150 cc/day (based on 20%), beer > 750 cc/day (based on 4%), liquor > 75 cc/day (based on 40%) , wine > 300 cc/day (based on 10%))
  • Those who have smoked excessively within 28 days before the first administration (cigarettes > 10 cigarettes/day) or those who could not quit smoking during the clinical trial
  • Those who have consumed excessive caffeine within 28 days before the first administration (coffee > 5 cups/day, tea > 1250 cc/day, coke 1250 cc/day)
  • Those who consume alcohol continuously or are unable to abstain from alcohol during the clinical trial
  • Those who are judged unsuitable for participation in the clinical trial by the investigator (study doctor) for other reasons, including the results of clinical laboratory tests

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Insan Medical Foundation Metro Hospital

    Anyang-si

Other trials in South Korea

About this study

Official title: An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability Between NDC-002A/NDC-002B and NDC-002C in Healthy Volunteers

An Open-label, One-sequence, Three-period, Multiple-dose Study to Evaluate Drug-drug Interactions, Safety and Tolerability between NDC-002A/NDC-002B and NDC-002C in Healthy Volunteers

Read the detailed description

This is an Open-label, One-sequence, Three-period, Multiple-dose Study and the goal of this clinical trial is to evaluate in health Volunteers.

The main question[s] it aims to answer are:

  • Drug-drug Interactions
  • Safety
  • Tolerability

The study consisted of Three-period: Period 1 which repeated administration of NDC-002C for 7 days and Period 2 which repeated administration of NDC-002A for 7 days, followed by administration of NDC-002B for 8 days and Period 3 which repeated concomitant administration of NDC-002B and NDC-002C for 7 days.

Being tested
NDC-002
Medical subject headings
Stroke

What participants receive

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

  • NDC-002Drug

    Combination of NDC-002B and NDC-002C

Study groups in NCT06090474
Study groupRoleWhat they receive
NDC-002ExperimentalIn Period 1, Two tablets of NDC-002C are repeatedly administered once a day for seven days to reach a steady state of NDC-002C. There is a seven-day washout period between Period 1 and Period 2. In Period 2, after repeated administration of one tablet of NDC-002A once a day for seven days, one tablet of NDC-002B is administered repeatedly once a day for eight days to reach a steady state of NDC-002B. In Period 3, after the completion of Period 2 administration and without a washout period, one tablet of NDC-002B and two tablets of NDC-002C administered repeatedly in combination once a day for seven days.
Receives: Drug: NDC-002

What is being measured

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

  1. Safety Evaluation: Adverse events

    Subjective/objective symptoms

    Measured: Up to 10 days post final dose

  2. Pharmacokinetic Evaluation: AUCss,τ of NDC-002B/C

    after single and concomitant administration of NDC-002B/C

    Measured: Day 1, Day 7, Day15, Day 29, Day 36

  3. Pharmacokinetic Evaluation: Css,max of NDC-002B/C

    after single and concomitant administration of NDC-002B/C

    Measured: Day 1, Day 7, Day15, Day 29, Day 36

Secondary outcomes (3)

  1. Pharmacokinetic Evaluation: AUCss,inf of NDC-002B/C

    after single and concomitant administration of NDC-002B/C

    Measured: Day 1, Day 7, Day15, Day 29, Day 36

  2. Pharmacokinetic Evaluation: Tss,max of NDC-002B/C

    after single and concomitant administration of NDC-002B/C

    Measured: Day 1, Day 7, Day15, Day 29, Day 36

  3. Pharmacokinetic Evaluation: Tss,1/2 of NDC-002B/C

    after single and concomitant administration of NDC-002B/C

    Measured: Day 1, Day 7, Day15, Day 29, Day 36

Timeline

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

  1. First posted19 Oct 2023
  2. Study start12 Jan 2023
  3. Primary completion15 Mar 2023
  4. Study completion15 Mar 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06090474
Sponsor's protocol ID
NDC002-P001
Status last verified
Oct 2023
First submitted
6 Oct 2023
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NDC-002 in people with Stroke Sequelae and Stroke, run by Dr. Noah Biotech Inc. 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 7 inclusion and 28 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 24 Oct 2023. 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?

Safety Evaluation: Adverse events (time frame: Up to 10 days post final dose). The study lists 3 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 NCT06090474.

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 24 Oct 2023.

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