A Study to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 in Healthy Male Subjects

NCT04485884 | Unknown Phase 1 DMC

• 1 other identifier: IN_BTK_101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]

  Cmax of IN-C005

  Up to 48 hours

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects), Multiple Dosing Group (Caucasian Subjects)]

  AUClast of IN-C005

  Up to 48 hours

• Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]

  Cmax,ss of IN-C005

  Up to 48 hours

• Pharmacokinetic Evaluation [Multiple Dosing Group (Caucasian Subjects)]

  AUCtau,ss of IN-C005

  Up to 48 hours

Secondary Outcomes (41)

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]

  Up to 48 hours

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]

  Up to 48 hours

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]

  Up to 48 hours

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]

  Up to 48 hours

• Pharmacokinetic Evaluation [Single Dosing Group (Korean Subjects)]

  Up to 48 hours

Study Arms (6)

Group A

EXPERIMENTAL

IN-C005 dose A

Drug: IN-C005 dose A

Group B

EXPERIMENTAL

IN-C005 dose B

Drug: IN-C005 dose B

Group C

EXPERIMENTAL

IN-C005 dose C

Drug: IN-C005 dose C

Group D

EXPERIMENTAL

IN-C005 dose D

Drug: IN-C005 dose D

Group E

EXPERIMENTAL

IN-C005 dose E

Drug: IN-C005 dose E

Group F

EXPERIMENTAL

IN-C005 dose F

Drug: IN-C005 dose F

Interventions

IN-C005 dose A DRUG

One time dose of IN-C005 dose A taken orally.

Also known as: IN-C005

Group A

IN-C005 dose B DRUG

One time dose of IN-C005 dose B taken orally.

Also known as: IN-C005

Group B

IN-C005 dose C DRUG

One time dose of IN-C005 dose C taken orally.

Also known as: IN-C005

Group C

IN-C005 dose D DRUG

Oral administration of IN-C005 dose D once daily for 7 days.

Also known as: IN-C005

Group D

IN-C005 dose E DRUG

Oral administration of IN-C005 dose E once daily for 7 days.

Also known as: IN-C005

Group E

IN-C005 dose F DRUG

Oral administration of IN-C005 dose F once daily for 7 days.

Also known as: IN-C005

Group F

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \[For single dosing group only\] Healthy Korean male aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF)
• \[For multiple dosing group only\] Healthy Caucasian male aged 19 to 50 years (inclusive) at the time of signing the ICF (Caucasian subject is defined as a European who was born in Europe, has the duration of residence outside of Europe less than 10 years, and both of whose parents and grandparents are European-born).
• Body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2 with a body weight ≥ 55.0 kg at screening. (BMI (kg/m2) = weight (kg) / {height (m)}2)
• Subjects with negative result in serum Helicobacter pylori antibody test.
• Voluntary participation in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure
• Subjects who are eligible for this study in the opinion of the investigator based on the results of physical examination, clinical laboratory tests, interview, etc.

You may not qualify if:

• History or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
• History or current evidence of gastrointestinal disease that may affect the safety and PD assessment for study treatment (e.g., gastrointestinal ulcer, gastritis, gastric cramp, gastroesophageal reflux disease, and Crohn's disease) or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
• History or current evidence of clinically significant hypersensitivity to drugs containing IN-C005 or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
• Subjects with positive result on serology tests (for hepatitis B, human immunodeficiency virus \[HIV\], and hepatitis C).
• Subjects with blood level of total bilirubin, AST (GOT), or ALT (GPT) \> 1.5 X upper limit of normal range(ULN) at procedures performed during the screening period including those performed additionally.
• Subjects with eGFR \< 60 ml/min/1.73m2 during the screening period including those performed additionally.
• Systolic blood pressure (SBP) of \< 90 mmHg or \> 140 mmHg, diastolic blood pressure (DBP) of \< 50 mmHg or \> 95 mmHg, or pulse rate of \< 45 beats/min or \> 100 beats/min on vital signs as measured in sitting position after taking a rest for at least 5 minutes at screening.
• Subjects with anatomical disorder that precludes insertion and maintenance of intragastric pH meter catheter or is expected to be intolerable to insertion of intragastric pH meter catheter.
• History of drug abuse or positive response to drug abuse on urine drug screening test.
• Subjects who received any prescription drug or herbal medication within 2 weeks of or any over-the-counter (OTC) drug, dietary supplements, or vitamins within 1 week of scheduled first dose or subjects who are expected to receive such medication during the study. (Note: a subject may participate in the study at the discretion of the investigator, provided that the subject meets all the other criteria).
• Subjects who participated in any other clinical study or bioequivalence study and received investigational product within 6 months prior to the scheduled first dose.
• Subjects who have donated whole blood within 2 months prior to the scheduled first dose, or have donated blood components or received transfusion within a month prior to the scheduled first dose.
• Excessive caffeine intake (\> 5 units/day), continued use of alcohol (\> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to stop drinking while hospitalized.
• Positive result for cotinine on urine drug screening test or inability to quit smoking throughout the study.
• Subjects who have taken grapefruit-containing foods during the period from 24 hours (hrs) before hospitalization to discharge, or are unable to avoid grapefruit-containing foods during this period.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• In-Jin Jang, MD, PhD

  Seoul National University Hospital, Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngshin Keum, R.Ph, Pharm.D

CONTACT

+82-2-6477-0204; ys.keum@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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 24, 2020
• Study Start: August 13, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 9, 2020

Record last verified: 2020-07

Locations

KR (1)