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HealthyPhase 1NCT05207176

Study to Evaluate the Safety and PK Properties of DWP16001 in Healthy Subjects With Various Ethnicities

A Phase 1 study testing DWP16001 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics Read more about this study

Who is it for?
Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DWP16001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
14 Feb 2022to 31 Aug 2022
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. A healthy adult between 19 and 50 years of age at the time of screening 2. Koreans, Caucasian, and Hispanics are classified according to the following criteria.
  • Korean: A Korean ethnic group born in Korea or outside Korea who has lived abroad for 10 years and has Korean parents and grandparents.
  • Caucasian: Born in Europe, living abroad in Europe for 10 years, Europeans with European parents and grandparents
  • Hispanic: Subjects of Latin American races with parents and grandparents who are Latin American, having nationalities from Mexico, Puerto Rico, Cuba, Latin America, or other Spanish cultures.
  • 3. At the time of screening test, if the weight is more than 50.0 kg or less than 90.0 kg, the body mass index (BMI) is 18.0 kg/m^2 or more 30.0 kg/m^2 or less (body mass index, kg /m^2) = weight (kg) / [height (m)] 2) 4. In the case of female volunteers, factors such as not necessarily pregnant or lactating or surgical infertility (both difficulty tube closure, hysterectomy, both difficulty tube resection, both ovarian resection, etc.) 5. A person who has heard sufficient explanation of this clinical trial and fully understood it, voluntarily decided to participate, and agreed in writing to comply with precautions.

Who cannot join

  • Clinically significant hepatometer (severe liver disorder, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood • tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system, etc.
  • A person who has a history of hypersensitivity or clinically significant hypersensitivity to DWP16001 and other drugs (aspirin, antibiotics, etc.), including homogeneous drugs.
  • Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery that may affect the safety and pharmacokinetic/pharmacodynamic evaluation of DWP16001 (however, simple appendicectomy, excluding hernia surgery)
  • The person who showed the following results in the screening test. 1) Blood AST (SGOT), ALT (SGPT):> Upper limit of normal range × 1.5 2) Creatine cleaning rate calculated through MDRD equation: <90 mL/min 3) Serum glucose on an empty stomach: >110 mg/dL or <70 mg/dL 4) Serum test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) results are positive factors.
  • Those with a systolic blood pressure <90 mmHg or >150 mmHg or diastolic blood pressure <60 mmHg or >100 mmHg in vital signs measured in the sitting position after resting for more than 3 minutes
  • Those who have a history of drug abuse or who have tested positive for drugs of abuse in urine screening tests
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  • Those who have taken any prescription drugs or herbal medicines within 2 weeks before the expected first dose, or have taken any over-the-counter (OTC) drugs, health functional foods, or vitamins within 1 week (however, different conditions according to the judgment of the researcher) In this reasonable case, you can participate in the clinical trial) or those who are expected to take it
  • Those who have taken drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the expected first administration date
  • A person who participated in other clinical trials (including biological equivalence tests) and administered drugs for clinical trials within 6 months of the expected first dose date.
  • A person who donated whole blood within 2 months prior to the expected first dose or donated ingredients within 1 month prior to the expected first dose date, or received a blood transfusion within 1 month prior to the expected first dose date.
  • A person who is unable to drink continuously (exceeds 21 units/week, 1 unit = 10 g of pure alcohol) or to abstain from drinking during the period from 3 days before the expected first administration date to the last discharge.
  • A current smoker (however, if he/she quit smoking three months before the expected first dose date, he/she can be selected as a test subject) or a person who cannot stop smoking during the period from the time of discharge.
  • Those who cannot refrain from eating grapefruit (grapefruit)-containing food during the period from 3 days before the expected first administration date to the last discharge
  • A person who continuously consumed excessive caffeine (> 5 units/day) or who cannot prohibit the intake of caffeine/caffeine-containing foods (coffee, tea (black tea, green tea, etc.), soda, coffee milk, nutritional tonic drinks, etc.) during the expected first 3 days to the last discharge.
  • Those who cannot use an appropriate double contraceptive method or medically acceptable method of contraception for themselves, their spouse, or their partner during the entire clinical trial period, and those who do not agree not to donate sperm or eggs until the relevant period
  • Medically acceptable contraceptive method
  • The use of intrauterine devices with proven pregnancy failure rates in oneself or spouse (or partner)
  • Use of both blocking contraception method (for men or women) and skin killer at the same time.
  • Surgery of the person or partner (vascularization, arthroplasty/ligation, hysterectomy
  • Those who do not meet the above selection criteria or who are judged by the researcher as unsuitable to participate in the clinical trial due to reasons other than those that fall under the exclusion criteria

About this study

Official title: An Open-label, Single-center, Parallel, Single and Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP16001 in Healthy Koreans, Caucasians, and Hispanics

An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics

Read the detailed description

This study is conducted with single center, parallel design, single and repeated administration and repeated administration.

  1. Screening (28d~ 2d) For volunteers, screening tests such as questionnaire, physical examination and clinical examination are conducted within 4 weeks (-28d~-2d) from the date of administration of the clinical investigational drug (1d), and subjects judged to be suitable for this clinical trial are selected.
  2. Dosing and Pharmacokinetics/Pharmacodynamic Evaluators (1d to 12d) The subjects who are judged to be suitable for this clinical trial are admitted to the clinical trial center of Seoul National University Hospital in the afternoon of 1 day (-1d) before administration. In order to maintain an empty stomach for at least 10 hours before administration of clinical trial drugs, fast except for drinking water after 10 p.m.
  3. PSV (17d ~ 21d) The post-study visit is conducted on 17d to 21d, about one week after the last dosing date.
Conditions
Healthy
Being tested
DWP16001

What participants receive

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

  • DWP16001Drug

    Subjects should fast except for drinking water after 10 p.m. in order to maintain a fasting state for at least 10 hours before administration. On dosing days (5d to 10d), except for 1d and 11d, breakfast can be consumed from about 1 hour after administration of the clinical trial drug. Subjects should swallow the investigational drug whole with 150 mL of water, and should not chew the drug before swallowing. Subjects should fast for 4 hours after dosing, and can drink water freely from 2 hours after dosing.

Study groups in NCT05207176
Study groupRoleWhat they receive
DWP16001ExperimentalTotal number of subjects: 24 (8 Korean, 8 Caucasian, and 8 Hispanic)
Receives: Drug: DWP16001

What is being measured

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

  1. Cmax

    Cmax of plasma DWP16001

    Measured: Single dose: 0 (pre-dose), 0.25 to 96 hours post dose on Day 1, Multi-dose: 0 (pre-dose), 0.25 to 24 hours post dose on Day 11

  2. AUClast

    AUClast of plasma DWP16001

    Measured: Single dose: 0 (pre-dose), 0.25 to 96 hours post dose on Day 1, Multi-dose: 0 (pre-dose), 0.25 to 24 hours post dose on Day 11

Timeline

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

  1. First posted26 Jan 2022
  2. Study start14 Feb 2022 (estimated)
  3. Primary completion8 Apr 2022 (estimated)
  4. Study completion31 Aug 2022 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207176
Sponsor's protocol ID
DW_DWP16001107
Status last verified
Nov 2021
First submitted
12 Jan 2022
Last updated
26 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DWP16001 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..

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 20 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Cmax (time frame: Single dose: 0 (pre-dose), 0.25 to 96 hours post dose on Day 1, Multi-dose: 0 (pre-dose), 0.25 to 24 hours post dose on Day 11). 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 NCT05207176.

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 26 Jan 2022.

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