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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019755
• Other study ID #: IN_JSI_103
• Status: Recruiting
• Phase: Phase 1
• Start date: August 13, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: August 2021
• Source: HK inno.N Corporation
• Contact: Sohyun Kim, BS
• Phone: +82-2-6477-0225
• Email: sohyun.kim21[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

To explore the effect of High-fat diet on the pharmacokinetics of single dose of IN-A002 capsule in healthy male subjects

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• IN-A002(IN-115314) capsule
Oral Administration of IN-A002(IN-115314), single dose
• IN-A002(IN-115314) capsule
Oral Administration of IN-A002(IN-115314), single dose

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital, Dept. of Clinical Pharmacology	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of IN-A002(IN-115314)		up to 72 hours
Primary	AUClast of IN-A002(IN-115314)		up to 72 hours
Secondary	AUCinf of IN-A002(IN-115314)		up to 72 hours
Secondary	Tmax of IN-A002(IN-115314)		up to 72 hours
Secondary	t1/2 of IN-A002(IN-115314)		up to 72 hours
Secondary	?z of IN-A002(IN-115314)		up to 72 hours
Secondary	CL/F of IN-A002(IN-115314)		up to 72 hours
Secondary	Vd/F of IN-A002(IN-115314)		up to 72 hours
Secondary	Cmax of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	AUClast of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	AUCinf of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	Tmax of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	t1/2 of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	?z of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours
Secondary	Metabolite ratio of IN-116118(primary metabolite of IN-A002(IN-115314))		up to 72 hours