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Gastro-Intestinal DisorderPhase 1NCT06393881

A Study to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of UI059 and UIC202201

A Phase 1 study testing UI059 and UIC202201 in people with Gastro-Intestinal Disorder, run by Korea United Pharm. Inc. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Gastro-Intestinal Disorder
What is being tested?
UI059 and UIC202201
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSouth Korea
Study dates
3 Jul 2024to 21 Sep 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • healthy adult volunteers aged 19 and above.
  • For males, a weight of 50.0 kg or more, and for females, a weight of 45.0 kg or more, with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2.
  • BMI(kg/m2)=Weight(kg)/height(m)2
  • No congenital or chronic diseases requiring treatment, and no pathological symptoms or findings based on internal medicine examination.
  • Those who were determined to be suitable subjects for clinical trials as a result of tests such as clinical laboratory tests, vital signs, physical examination (physical examination), and 12-lead electrocardiogram
  • Negative for H. pylori antibodies
  • After receiving detailed explanations about the clinical trial and fully understanding, participants voluntarily decide to participate and provide written consent to adhere to the subject compliance requirements throughout the trial period.

Who cannot join

  • Current or past medical history of clinically significant conditions involving the liver, kidneys, nervous system, mental health, respiratory system, endocrine system, blood disorders, tumors, genitourinary system, cardiovascular system, digestive system, musculoskeletal system, etc., and in addition:
  • currently receiving antiretroviral drugs (rilpivirine, atazanavir, nelfinavir)
  • liver disorders
  • kidney disorders
  • History of gastrointestinal conditions (Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of the investigational drug.
  • Pregnant (positive Urine-HCG) or lactating for female participants
Show all 27Show fewer
  • Have a history of hypersensitivity reactions (such as anaphylaxis or angioedema) or clinically significant hypersensitivity reactions to drugs, excipients, or other substances, including medications containing the active ingredients of the investigational drug, additives, and other drugs (such as aspirin, penicillin antibiotics, macrolide antibiotics).
  • Have clinically significant findings on the 12-lead electrocardiogram during screening, including:
  • QTc interval > 450 ms for males or > 470 ms for females.
  • PR interval > 200 ms.
  • QRS duration > 120 ms.
  • Showing the following results in clinical trial laboratory tests during screening:
  • liver function assessment: AST, ALT, ALP, γ-GTP, and total bilirubin exceeding twice the upper limit of the normal range.
  • Blood creatinine levels outside the reference range or calculated estimated glomerular filtration rate (eGFR) using the CKD-EPI formula less than 60 mL/min/1.73m2.
  • History of drug abuse or individuals who have shown a positive reaction for abused substances in a urine drug test.
  • During screening, exhibit vital signs measured after at least 3 minutes of rest in a seated position with systolic blood pressure (SBP) ≥ 150 mmHg or ≤ 90 mmHg, diastolic blood pressure (DBP) ≥ 100 mmHg or ≤ 60 mmHg, or a heart rate (HR) ≤ 40 bpm or ≥ 100 bpm.
  • Have an abnormal diet that could affect the absorption, distribution, metabolism, or excretion of the investigational drug, or individuals who consume foods that could impact drug metabolism.
  • Administered any prescription medications or herbal products that could influence the characteristics of the investigational drug within 2 weeks before the first dose or any OTC drugs or vitamin supplements within 10 days before the first dose. (If there is no effect on the pharmacokinetic properties of this investigational drug, the investigator may participate in the clinical trial at the discretion of the investigator.)
  • Administer drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first administration date.
  • Participated in other clinical trials within 6 months prior to the first administration date (The endpoint for determining the end of participation in another clinical trial is considered one day after the last administration in that trial.)
  • Those who have consistently consumed alcohol in excess of 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) within 6 months prior to the first administration date or who are unable to abstain from alcohol from the time of written consent to the time of PSV.
  • Smokers who smoke more than 10 cigarettes on average per day within 3 months before the first administration date and those who are unable to quit smoking from 24 hours before each administration until the time of the last blood collection
  • Consumed food containing grapefruit or cannot refrain from eating it from 48 hours before the first administration until the time of PSV
  • Those who consumed caffeine-containing foods (coffee, green tea, black tea, carbonated drinks, coffee milk, tonic drinks, etc.) during the period from 24 hours before administration to the time of the last blood collection, or who cannot refrain from consuming them.
  • Those who engaged in vigorous exercise exceeding the level of daily life during the period from 48 hours before the first administration to the time of PSV, or who cannot refrain from vigorous exercise
  • From the time of the subject's written consent until 2 weeks after the last administration of the investigational drug, even if the person, spouse, or partner is planning to become pregnant or is not planning to become pregnant, a recognized method of contraception (e.g., administration of contraceptives, implantation or intrauterine device, sterilization procedure (vasectomy), not using surgical resection, tubal ligation, etc.) or blocking methods (combined use of spermicides, condoms, contraceptive diaphragms, vaginal sponges, or cervical caps)
  • Judged by the investigator to be unsuitable for participation in clinical trials due to reasons other than the above selection/exclusion criteria

Trial locations and contacts

1 site in 1 country.

Minkyu Park, MD, PhD contact

+82432698708

mk_park@cbnuhctc.com

South Korea1 site

  • Chungbuk national university hospital

    Cheongju-si, North Chungcheong, 28644

    Minkyu Park, MD, PhD, +821057170713, mk_park@cbnuhctc.com

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose Crossover Phase 1 Clinical Trial to Compare and Evaluate the Safety, Pharmacokinetics and Pharmacodynamics Characteristics After Oral Administration of UI059 and UIC202201 in Healthy Adult Volunteers

A randomized, open-label, multiple-dose crossover phase 1 clinical trial to compare and evaluate the safety, pharmacokinetics and pharmacodynamics characteristics after oral administration of UI059 and UIC202201 in healthy adult volunteers

Being tested
UI059, UIC202201
Medical subject headings
Digestive System Diseases

What participants receive

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

  • UI059Drug

    Also called Test

    take UI059 once a day for 7 days

  • UIC202201Drug

    Also called Reference

    take UIC202201 once a day for 7 days

Study groups in NCT06393881
Study groupRoleWhat they receive
UI059ExperimentalNot described
Receives: Drug: UI059
UIC202201Active comparatorNot described
Receives: Drug: UIC202201

What is being measured

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

  1. AUCtau,ss

    Area under the plasma concentration-time curve within a dosing interval at steady state

    Measured: Day 1: 0~24hours / Day 5, 6: 0hours / Day 7: 0~24hours

  2. Percent decrease from baseline in integrated gastric acidity

    Percent decrease from baseline in integrated gastric acidity for 24 hours after multiple(7th dose) administrations

    Measured: Day -1~Day 1, Day 1~Day 2, Day 7

Timeline

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

  1. First posted1 May 2024
  2. Study start3 Jul 2024 (estimated)
  3. Primary completion14 Sep 2024 (estimated)
  4. Study completion21 Sep 2024 (estimated)

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
Randomised
Intervention model
Crossover
Model description
A randomized, open-label, multiple-dose crossover phase 1 clinical trial
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393881
Sponsor's protocol ID
KUP-UI059-102
Status last verified
Apr 2024
First submitted
28 Apr 2024
Last updated
1 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UI059 and UIC202201 in people with Gastro-Intestinal Disorder, run by Korea United Pharm. 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 27 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minkyu Park, MD, PhD (+82432698708, mk_park@cbnuhctc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCtau,ss (time frame: Day 1: 0~24hours / Day 5, 6: 0hours / Day 7: 0~24hours). 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 NCT06393881.

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 1 May 2024.

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