Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians

NCT05005065 | Completed Phase 1

• 1 other identifier: IN_BTK_102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Cmax

  PK: Maximum concentration of drug in plasma

  Day 1, Day 22

• AUClast

  PK: Area under the plasma drug concentration-time curve from 0 to last point of measurable concentration

  Day 1, Day 22

• Cmax,ss

  PK: Maximum (peak) steady-state plasma drug concentration during a dosage interval

  Day 7 and Day 28

• AUCtau,ss

  PK: Area under the plasma drug concentration-time curve for a dosing interval at steady state

  Day 7 and Day 28

• Percent duration of pH ≥4 in 24 hrs (duration %)

  PD: pH parameter

  Day 1, Day 22

• Percent duration of pH ≥4 in 24 hrs (duration %)

  PD: pH parameter

  Day 7, Day 28

• Change from baseline in percent duration of pH ≥4 in 24 hrs

  PD: pH parameter

  Day 1, Day 7, Day 22, Day 28

Secondary Outcomes (24)

• AUCinf

  Day 1, Day 22

• Tmax

  Day 1, Day 22

• t1/2

  Day 1, Day 22

• CL/F

  Day 1, Day 22

• Vd/F

  Day 1, Day 22

Study Arms (4)

Treatment AB

EXPERIMENTAL

Participants will be randomized to receive IN-C005 Y mg (Treatment A) and IN-A001 Y mg (Treatment B) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2.

Drug: IN-A001 Y mg; Drug: IN-C005 Y mg

Treatment BA

EXPERIMENTAL

Participants will be randomized to receive IN-A001 Y mg and IN-C005 Y mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2.

Drug: IN-A001 Y mg; Drug: IN-C005 Y mg

Treatment CD

EXPERIMENTAL

Participants will be randomized to receive IN-C005 Z mg (Treatment C) and IN-C005 X mg (Treatment D) sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2.

Drug: IN-C005 X mg; Drug: IN-C005 Z mg

Treatment DC

EXPERIMENTAL

Participants will be randomized to receive IN-C005 X mg and IN-C005 Z mg sequentially in a two-period sequence. There will be a washout period of at least 14 days between Period 1 and Period 2.

Drug: IN-C005 X mg; Drug: IN-C005 Z mg

Interventions

IN-C005 X mg DRUG

Oral capsule

Treatment CD; Treatment DC

IN-A001 Y mg DRUG

Oral tablet

Treatment AB; Treatment BA

IN-C005 Y mg DRUG

Oral capsule

Treatment AB; Treatment BA

IN-C005 Z mg DRUG

Oral capsule

Treatment CD; Treatment DC

Eligibility Criteria

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

You may qualify if:

• Is healthy Caucasian adult aged 19 to 50 years (inclusive) at the time of signing the informed consent form (ICF) (A Caucasian 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).
• Has ≥ 18.0 and ≤ 30.0 kg/m2 of body mass index (BMI) with a body weight (BW) ≥ 55.0 kg at screening.
• Has a negative result in serum Helicobacter pylori IgG antibody test.
• Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his/her written informed consent prior to screening procedure.
• Is 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:

• 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 PD assessments 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).
• Has a history or current evidence of clinically significant hypersensitivity to study drugs or any ingredient of proton pump inhibitors and other drugs (such as aspirin and antibiotics).
• Has a positive result on serology tests (for hepatitis B, human immunodeficiency virus \[HIV\], and hepatitis C).
• Has a blood level of total bilirubin, AST (GOT), or ALT (GPT) \> 1.5 X upper limit of normal (ULN) based on screening procedures including repeated ones.
• Has a calculated eGFR per MDRD equation \< 60 mL/min/1.73 m2 based on screening procedures including repeated ones.
• Has systolic blood pressure (SBP) of \< 90 mmHg or \> 140 mmHg, diastolic blood pressure (DBP) of \< 50 mmHg or \> 95 mmHg, or pulse rate (PR) 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.
• Has an 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.
• Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
• Has 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 is expected to receive such medication during the study (Note: a subject may participate in the study at the discretion of the investigator provided the subject meets all the other criteria).
• Has participated and received an investigational agent in another clinical trial or bioequivalence study within 6 months prior to the first dose of study treatment (Note: This is not applied to participation in another part of this study).
• 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 excessive caffeine intake (\> 5 units/day), continues the use of alcohol (\> 21 units/week, 1 unit = 10 g of pure alcohol), or is unable to stop drinking during hospitalization period.
• Has a positive result for cotinine on urine drug screening test or is unable to stop smoking throughout the study.
• Is unable to avoid grapefruit-containing foods during the time from 24 hours (hrs) before hospitalization to discharge in Period 1 and Period 2, respectively.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (2)

Seoul National University Hospital

Seoul, Jongro Gu, 03080, South Korea

Location

Seoul National University Hopsital

Seoul, 03080, South Korea

Location

Study Officials

• In-Jin Jang, MD, Ph.D

  Clinical Pharmacology and Therapeutics, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, multiple dosing, crossover study

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: August 13, 2021
• Study Start: September 6, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 30, 2021
• Last Updated: May 16, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)