Idiopathic Pulmonary FibrosisPhase 1NCT04767815
To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
A Phase 1 study testing Diet A group, Diet B group and Diet C group in people with Idiopathic Pulmonary Fibrosis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Diet A group, Diet B group and Diet C group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2021to 4 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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)
- 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)
- Subjects determined to be ineligible to participate in the study by the investigator due to reasons other than those specified above
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
The pharmacokinetics 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
- Being tested
- Diet A group, Diet B group, Diet C group
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet A groupDrug
Fasting + DWN12088 200 mg
Diet B groupDrug
30 minutes after a high-fat meal + DWN12088 200 mg
Diet C groupDrug
2 hours after a high-fat meal + DWN12088 200 mg
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Diet A group; Drug: Diet B group; Drug: Diet C group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Measured: 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
Measured: 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
Measured: follow-up 26 days after dosing
Secondary outcomes (5)
AUCinf of DWN12088 and metabolite
To evaluate pharmacokinetics parameter
Measured: 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
To evaluate pharmacokinetics parameter
Measured: 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
To evaluate pharmacokinetics parameter
Measured: 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
To evaluate pharmacokinetics parameter
Measured: 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
To evaluate pharmacokinetics parameter
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start22 Mar 2021
- Primary completion31 May 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaeseong Oh, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767815
- Sponsor's protocol ID
- DW_DWN12088102
- Status last verified
- Aug 2021
- First submitted
- 15 Feb 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04767815
- Acronym / sponsor ID
- DW_DWN12088102
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The pharmacokinetics 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: A (Fasting) * Period 2: B (30 minutes after a High-fat meal) * Period 3: C (2 hours after a High-fat meal) |
| Sequence 2 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: B (30 minutes after a High-fat meal) * Period 2: C (2 hours after a High-fat meal) * Period 3: A (Fasting) |
| Sequence 3 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: C (2 hours after a High-fat meal) * Period 2: A (Fasting) * Period 3: B (30 minutes after a High-fat meal) |
| Sequence 4 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: A (Fasting) * Period 2: C (2 hours after a High-fat meal) * Period 3: B (30 minutes after a High-fat meal) |
| Sequence 5 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: C (2 hours after a High-fat meal) * Period 2: B (30 minutes after a High-fat meal) * Period 3: A (Fasting) |
| Sequence 6 | Experimental | Drug: Diet A group, Drug: Diet B group, Drug: Diet C group* Period 1: B (30 minutes after a High-fat meal) * Period 2: A (Fasting) * Period 3: C (2 hours after a High-fat meal) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet A groupFasting + DWN12088 200 mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Diet B group30 minutes after a high-fat meal + DWN12088 200 mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| Diet C group2 hours after a high-fat meal + DWN12088 200 mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
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
To evaluate pharmacokinetics parameter
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
To evaluate pharmacokinetics parameter
Adverse events (AEs) such as subjective and objective symptoms
Time frame: follow-up 26 days after dosing
To evaluate safety
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaeseong Oh principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diet A group, Diet B group and Diet C group in people with Idiopathic Pulmonary Fibrosis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 4 inclusion and 21 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: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2021.