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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT04767815
• Date of registration: 15/02/2021
• Prospective Registration: Yes
• Primary sponsor: Daewoong Pharmaceutical Co. LTD.
• Public title: To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
• Scientific title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
• Date of first enrolment: March 22, 2021
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04767815
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Contacts

• Name: Jaeseong Oh
• Affiliation: Seoul National University Hospital

Key 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

? 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 ? QTc interval > 450 ms ?
Positive result in serology (hepatitis B tests, hepatitis C tests, human
immunodeficiency virus [HIV] tests, syphilis tests) ? 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

? 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 ? 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) ? Physical and chemical
barrier contraception (male/female condom with spermicide, diaphragm, sponge,
cervical cap with spermicide, etc.) ? 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



Age minimum: 19 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Diet A group

Drug: Diet C group

Drug: Diet B group

Primary Outcome(s)

Adverse events (AEs) such as subjective and objective symptoms [Time Frame: follow-up 26 days after dosing]

AUClast of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

Cmax of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

Secondary Outcome(s)

AUCinf of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

Vd/F of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

t1/2 of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

CL/F of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

Tmax of DWN12088 and metabolite [Time Frame: Day 1, Day8 and Day15 of 0 hours, 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours]

Secondary ID(s)

DW_DWN12088102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors