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

NCT05207176 | Unknown Phase 1

• 1 other identifier: DW_DWP16001107
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  Cmax of plasma DWP16001

  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

• AUClast

  AUClast of plasma DWP16001

  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

Study Arms (1)

DWP16001

EXPERIMENTAL

Total number of subjects: 24 (8 Korean, 8 Caucasian, and 8 Hispanic)

Drug: DWP16001

Interventions

DWP16001 DRUG

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.

DWP16001

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Interventions

Enavogliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: February 14, 2022
• Primary Completion: April 8, 2022
• Study Completion: August 31, 2022
• Last Updated: January 26, 2022

Record last verified: 2021-11