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

NCT04767815 | Completed Phase 1

• 1 other identifier: DW_DWN12088102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (3)

• Cmax of DWN12088 and metabolite

  To evaluate pharmacokinetics parameter

  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

• AUClast of DWN12088 and metabolite

  To evaluate pharmacokinetics parameter

  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

• Adverse events (AEs) such as subjective and objective symptoms

  To evaluate safety

  follow-up 26 days after dosing

Secondary Outcomes (5)

• AUCinf of DWN12088 and metabolite

  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

  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

  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

  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

  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

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Sequence 2

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Sequence 3

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Sequence 4

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Sequence 5

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Sequence 6

EXPERIMENTAL

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

Drug: Diet A group; Drug: Diet B group; Drug: Diet C group

Interventions

Diet A group DRUG

Fasting + DWN12088 200 mg

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Diet B group DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Diet C group DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged ≥ 19 and ≤ 55 years at screening
• 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
• 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

You may not qualify if:

• Subjects with current or history of clinically significant hematological disorder, tumor, or immunologic, endocrine, psychiatric, neurological, cardiovascular, respiratory, digestive, hepatobiliary, renal, or urinary disorder
• 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)
• Subjects with clinically significant hypersensitivity to any drugs including the ingredient of the IP (DWN12088) or excipients
• 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
• 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
• 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
• Subjects who participated in another clinical study and received another IP within 180 days before the first dose of the IP
• 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
• 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)
• 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
• 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
• 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
• Subjects who are on or plan to receive CYP2D6 inducing/inhibiting drugs

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jaeseong Oh

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 23, 2021
• Study Start: March 22, 2021
• Primary Completion: May 31, 2021
• Study Completion: June 4, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

KR (1)