HealthyPhase 1NCT05019755
A Study to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
A Phase 1 study testing IN-A002(IN-115314) capsule in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IN-A002(IN-115314) capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2021to 24 Feb 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening. BMI (kg/m^2) = Weight(kg) / {Height(m)}^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview.
Who cannot join
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and Pharmacokinetics assessment of investigational product(IP) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
Show all 22Show fewer
- Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV], syphilis) during screening test.
- Has abnormalities one or more of the following during screening test: AST [GOT] or ALT [GPT] > 1.5 X upper limit of normal (ULN), Creatinine > upper limit of normal (ULN), ANC < 2,000/uL, Hb < 12.5 g/dL, Platelet < 150,000/uL, QTc interval at 12-lead electrocardiogram > 450 msec
- Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or > 95 mm Hg, or pulse rate (PR) < 45 beats/ min or > 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the scheduled first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator) or is expected to take such medication during the study.
- Has participated in any other clinical study, etc. and received IPs within 6 months prior to the scheduled first dose.
- Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- Has a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- Excessive caffeine intake (> 5 units/day) or continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol).
- Unable to stop drinking within 24 hrs prior to the scheduled first dose to post study visit.
- Unable to avoid caffeine-containing foods (e.g., coffee, tea [black tea, green tea, etc.], soda, coffee-flavored milk, and nutritive tonic drink, etc.) and foods containing grapefruit during each period from 24 hrs before hospitalization to discharge.
- Unable to use a medically acceptable contraceptive method stated below and does not agree not to donate sperm from the scheduled first dose to 90 days after the last dose.
- Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- Simultaneous use of (male or female) barrier method and spermicide
- Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- Determined ineligible for study participation by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital, Dept. of Clinical Pharmacology
Seoul
In-Jin Jang, MD, PhD, 82-2-2072-1666, ijjang@snu.ac.kr
About this study
Official title: A Randomized, Open-label, Single-dose, 2-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects
Read the detailed description
To explore the effect of High-fat diet on the pharmacokinetics of single dose of IN-A002 capsule in healthy male subjects
- Conditions
- Healthy
- Being tested
- IN-A002(IN-115314) capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-A002(IN-115314) capsuleDrug
Oral Administration of IN-A002(IN-115314), single dose
IN-A002(IN-115314) capsuleDrug
Oral Administration of IN-A002(IN-115314), single dose
| Study group | Role | What they receive |
|---|---|---|
| A(First period) to B(Second period) order | Experimental | A: Oral Administration of IN-A002(IN-115314) in fasting status
B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet
There will be a wash out period of 7days between period Receives: Drug: IN-A002(IN-115314) capsule |
| B(First period) to A(Second period) order | Experimental | B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet
A: Oral Administration of IN-A002(IN-115314) in fasting status
There will be a wash out period of 7days between period Receives: Drug: IN-A002(IN-115314) capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of IN-A002(IN-115314)
Measured: up to 72 hours
AUClast of IN-A002(IN-115314)
Measured: up to 72 hours
Secondary outcomes (13)
AUCinf of IN-A002(IN-115314)
Measured: up to 72 hours
Tmax of IN-A002(IN-115314)
Measured: up to 72 hours
t1/2 of IN-A002(IN-115314)
Measured: up to 72 hours
λz of IN-A002(IN-115314)
Measured: up to 72 hours
CL/F of IN-A002(IN-115314)
Measured: up to 72 hours
Vd/F of IN-A002(IN-115314)
Measured: up to 72 hours
Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
λz of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start13 Aug 2021
- Primary completion24 Feb 2022 (estimated)
- Study completion24 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital, Dept. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019755
- Sponsor's protocol ID
- IN_JSI_103
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 25 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2-way Crossover Clinical Trial to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05019755
- Acronym / sponsor ID
- IN_JSI_103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 24 Feb 2022 (estimated)
- Study completion
- 24 Feb 2022 (estimated)
- First posted
- 25 Aug 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.
This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects
Detailed description
To explore the effect of High-fat diet on the pharmacokinetics of single dose of IN-A002 capsule in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(First period) to B(Second period) order | Experimental | Drug: IN-A002(IN-115314) capsuleA: Oral Administration of IN-A002(IN-115314) in fasting status B: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet There will be a wash out period of 7days between period |
| B(First period) to A(Second period) order | Experimental | Drug: IN-A002(IN-115314) capsuleB: Oral Administration of IN-A002(IN-115314), 30 minutes after high-fat diet A: Oral Administration of IN-A002(IN-115314) in fasting status There will be a wash out period of 7days between period |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening. BMI (kg/m^2) = Weight(kg) / {Height(m)}^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview.
Key exclusion criteria (22 listed)
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and Pharmacokinetics assessment of investigational product(IP) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
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 |
|---|---|---|
| IN-A002(IN-115314) capsuleOral Administration of IN-A002(IN-115314), single dose | Drug | A(First period) to B(Second period) order |
| IN-A002(IN-115314) capsuleOral Administration of IN-A002(IN-115314), single dose | Drug | B(First period) to A(Second period) order |
Primary outcome
Cmax of IN-A002(IN-115314)
Time frame: up to 72 hours
AUClast of IN-A002(IN-115314)
Time frame: up to 72 hours
13 secondary outcomes
AUCinf of IN-A002(IN-115314)
Time frame: up to 72 hours
Tmax of IN-A002(IN-115314)
Time frame: up to 72 hours
t1/2 of IN-A002(IN-115314)
Time frame: up to 72 hours
λz of IN-A002(IN-115314)
Time frame: up to 72 hours
CL/F of IN-A002(IN-115314)
Time frame: up to 72 hours
Vd/F of IN-A002(IN-115314)
Time frame: up to 72 hours
Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
λz of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))
Time frame: up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
In-Jin Jang, MD, PhD principal investigator
Seoul National University Hospital, Dept. of Clinical Pharmacology
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 IN-A002(IN-115314) capsule in people with Healthy, run by HK inno.N Corporation 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 22 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: status not confirmed, as of the sponsor's last update on 25 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohyun Kim, BS (+82-2-6477-0225, sohyun.kim21@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of IN-A002(IN-115314) (time frame: up to 72 hours). The study lists 2 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 25 Aug 2021.