A Study to Investigate the Effect of Food on the Pharmacokinetics of IN-A002 Capsule in Healthy Male Subjects

NCT05019755 | Unknown Phase 1

• 1 other identifier: IN_JSI_103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of food on the pharmacokinetics of IN-A002 capsule in healthy male subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax of IN-A002(IN-115314)

  up to 72 hours

• AUClast of IN-A002(IN-115314)

  up to 72 hours

Secondary Outcomes (13)

• AUCinf of IN-A002(IN-115314)

  up to 72 hours

• Tmax of IN-A002(IN-115314)

  up to 72 hours

• t1/2 of IN-A002(IN-115314)

  up to 72 hours

• λz of IN-A002(IN-115314)

  up to 72 hours

• CL/F of IN-A002(IN-115314)

  up to 72 hours

Study Arms (2)

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

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

Drug: IN-A002(IN-115314) capsule

Interventions

IN-A002(IN-115314) capsule DRUG

Oral Administration of IN-A002(IN-115314), single dose

A(First period) to B(Second period) order

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital, Dept. of Clinical Pharmacology

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Capsules

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• In-Jin Jang, MD, PhD

  Seoul National University Hospital, Dept. of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohyun Kim, BS

CONTACT

+82-2-6477-0225; sohyun.kim21@inno-n.com

Seokuee Kim, MD, PhD

CONTACT

+82-2-6477-0207; seokuee.kim@inno-n.com

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: August 9, 2021
• First Posted: August 25, 2021
• Study Start: August 13, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

KR (1)