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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: IN-A002(IN-115314) capsule

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sohyun Kim, BS; Phone Number: +82-2-6477-0225; Email: sohyun.kim21@inno-n.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital, Dept. of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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.

  1. Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
  2. Simultaneous use of (male or female) barrier method and spermicide
  3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A(First period) to B(Second period) order; 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; Oral Administration of IN-A002(IN-115314), single dose
Experimental: B(First period) to A(Second period) order; 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; Oral Administration of IN-A002(IN-115314), single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of IN-A002(IN-115314)	up to 72 hours
AUClast of IN-A002(IN-115314)	up to 72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Vd/F of IN-A002(IN-115314)	up to 72 hours
Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
λz of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours
Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))	up to 72 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Anticipated): February 24, 2022
• Study Completion (Anticipated): February 24, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phospholipase A2 Inhibitors; Varespladib methyl
• Other Study ID Numbers: IN_JSI_103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No