Learn about Research & Clinical Trials

To Evaluate the Effect of Food on the the Pharmacokinetics and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers

Study Purpose

The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Healthy adults aged ≥ 19 and ≤ 55 years at screening. 2. Subjects with body weight ≥ 55.0 kg (male) or ≥ 45.0 kg (female) with a body mass index (BMI) of ≥ 18.0 kg/m2 to < 27.0 kg/m2 at screening test. ☞ BMI (kg/m2) = Body weight (kg) / {Height (m)}2. 3. Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study.

Exclusion Criteria:

1. Subjects with current or history of clinically significant hematological disorder, tumor, or immunologic, endocrine, psychiatric, neurological, cardiovascular, respiratory, digestive, hepatobiliary, renal, or urinary disorder. 2. Subjects with a history of a gastrointestinal disorder (gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.) or surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK assessment of the investigational product (IP) 3. Subjects with clinically significant hypersensitivity to any drugs including the ingredient of the IP (DWN12088) or excipients. 4. Subjects determined ineligible for meeting the one of the following on the screening tests conducted within 28 days prior to administration of the IP administration. ① AST or ALT > 1.5 times the upper limit of normal.
  • - Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 based on the modification of diet in renal disease (MDRD) formula ③ QTc interval > 450 ms ④ Positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus [HIV] tests, syphilis tests) ⑤ Sitting systolic blood pressure > 150 mmHg or < 90 mmHg or sitting diastolic blood pressure > 100 mmHg or < 50 mmHg after resting for more than 3 minutes.
5. Subjects with a history of drug abuse or positive result of using abusive drugs in urine drug screening test within 1 year prior to screening. 6. Subjects who used any prescription drugs or herbal medicines within 14 days, or any over-the-counter (OTC) drugs including dietary supplements and vitamin supplements within 7 days prior to the first dose of the IP which are judged to impact the study or the subject's safety by the investigator. 7. Subjects who participated in another clinical study and received another IP within 180 days before the first dose of the IP. 8. Subjects who donated whole blood within 60 days, donated blood components within 30 days, or received blood transfusion within 30 days prior to the first dose of the IP. 9. Subjects who consistently consumed excessive amount of caffein or alcohol (caffein > 5 cups/day, alcohol > 210 g/week) or are unable to refrain from caffein or alcohol intake from 3 days before the first dose to the post study visit (PSV) 10. Subjects who are current smokers (may be selected as subjects if they stopped smoking more than 180 days prior to the first dose of the IP) or unable to stop smoking from 180 days prior to the first dose of the IP to the PSV. 11. Subjects who used drugs inducing and inhibiting drug-metabolizing enzymes, such as barbital drugs, within 30 days prior to the first dose of the IP. 12. Subjects who consumed grapefruit, grapefruit juice, or grapefruit-containing products from 3 days prior to the first hospitalization to the last discharge of period 3, or are unable to refrain from the intake of grapefruit-containing products during this period. 13. Subjects who are on or plan to receive CYP2D6 inducing/inhibiting drugs. 14. Female subjects who are pregnant or lactating. ① All female subjects with childbearing potential except for those who are menopausal or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who have a positive pregnancy test (serum hCG or urine hCG) 15. Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration, and disagreed to refrain from donating sperms during this period.
  • - Caution: Woman of childbearing potential is defined as a woman who is not surgically sterile or post-menopausal.
Women amenorrhoeic for 12 months without an alternative medical cause will be considered as post-menopausal.
  • - Medically acceptable methods of contraception ① Use of intrauterine device (except for copper banded coil and hormonal device) for which pregnancy failure rate is proven, by a subject or spouse (or partner) ② Physical and chemical barrier contraception (male/female condom with spermicide, diaphragm, sponge, cervical cap with spermicide, etc.) ③ Surgical sterilization (vasectomy, salpingectomy, tubal ligation, and hysterectomy) of a subject or spouse (or partner) 16.
Subjects determined to be ineligible to participate in the study by the investigator due to reasons other than those specified above

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04767815
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Daewoong Pharmaceutical Co. LTD.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: Sequence 1

Period 1: A (Fasting) Period 2: B (30 minutes after a High-fat meal) Period 3: C (2 hours after a High-fat meal)

Experimental: Sequence 2

Period 1: B (30 minutes after a High-fat meal) Period 2: C (2 hours after a High-fat meal) Period 3: A (Fasting)

Experimental: Sequence 3

Period 1: C (2 hours after a High-fat meal) Period 2: A (Fasting) Period 3: B (30 minutes after a High-fat meal)

Experimental: Sequence 4

Period 1: A (Fasting) Period 2: C (2 hours after a High-fat meal) Period 3: B (30 minutes after a High-fat meal)

Experimental: Sequence 5

Period 1: C (2 hours after a High-fat meal) Period 2: B (30 minutes after a High-fat meal) Period 3: A (Fasting)

Experimental: Sequence 6

Period 1: B (30 minutes after a High-fat meal) Period 2: A (Fasting) Period 3: C (2 hours after a High-fat meal)

Interventions

Drug: - Diet A group

Fasting + DWN12088 200 mg

Drug: - Diet B group

30 minutes after a high-fat meal + DWN12088 200 mg

Drug: - Diet C group

2 hours after a high-fat meal + DWN12088 200 mg

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.