A Study to Explore Pharmacokinetics/Pharmacodynamics and Safety of Tegoprazan BID Dosing in Healthy Subjects

NCT04587011 | Unknown Phase 1

• 1 other identifier: IN_APA_119
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to explore the pharmacokinetics, pharmacodynamics and safety after twice-daily dosing of tegoprazan tablets in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

• Pharmacokinetics Evaluation

  Cmax of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  AUC0-t of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  AUC0-∞ of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  Tmax of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  t1/2β of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  CL/F of Tegoprazan

  Up to 24 hours

• Pharmacokinetics Evaluation

  Vd/F of Tegoprazan

  Up to 24 hours

• Pharmacokinetics Evaluation

  Css,max of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  Css,min of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetic Evaluation

  Css,avg of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  AUC48-72h of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  Tmax,ss of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  t1/2β,ss of Tegoprazan and M1

  Up to 24 hours

• Pharmacokinetics Evaluation

  CLss/F of Tegoprazan

  Up to 24 hours

• Pharmacokinetics Evaluation

  Vdss/F of Tegoprazan

  Up to 24 hours

Secondary Outcomes (9)

• Pharmacodynamics Evaluation

  24 hours

• Pharmacodynamics Evaluation

  24 hours

• Pharmacodynamics Evaluation

  24 hours

• Pharmacodynamics Evaluation

  24 hours

• Pharmacodynamics Evaluation

  24 hours

Study Arms (4)

T1

EXPERIMENTAL

Tegoprazan A mg or placebo

Drug: Tegoprazan dose A or placebo

T2

EXPERIMENTAL

Tegoprazan B mg or placebo

Drug: Tegoprazan dose B or placebo

T3

EXPERIMENTAL

Tegoprazan C mg or placebo

Drug: Tegoprazan dose C or placebo

T4

EXPERIMENTAL

Tegoprazan D mg or placebo

Drug: Tegoprazan dose D or placebo

Interventions

Tegoprazan dose A or placebo DRUG

Tegoprazan A mg or placebo taken orally twice daily for 3 days.

T1

Tegoprazan dose B or placebo DRUG

Tegoprazan B mg or placebo taken orally twice daily for 3 days.

T2

Tegoprazan dose C or placebo DRUG

Tegoprazan C mg or placebo taken orally twice daily for 3 days.

T3

Tegoprazan dose D or placebo DRUG

Tegoprazan D mg or placebo taken orally twice daily for 3 days.

T4

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged 19 to 45(inclusive) years at screening.
• Subjects with body mass index (BMI) in the range of 18.5 kg/m\^2 to 28.0 kg/m\^2(inclusive)
• Subjects who voluntarily agreed to participate in the study after being fully informed of the purpose, content, and characteristics of the investigational product(IP) prior to the study participation.

You may not qualify if:

• Past medical history
• Subjects who are determined by the investigator to have clinically significant history or disease related to the liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, urinary system and cardiovascular system including cardiac arrhythmia.
• Subjects who are determined by the investigator to have past history of gastrointestinal diseases (ex.: gastritis, GERD, Crohn's disease, ulcers etc.) or abdominal surgery (except simple appendectomy or herniotomy) that may affect the IP absorption.
• Diagnostic test and electrocardiogram (ECG)
• If H. pylori test result is positive at screening
• If the AST or ALT value is more than 1.25 times the upper limit of normal under the screening test
• If the total bilirubin value is more than 1.5 times the upper limit of normal under the screening test
• If the eGFR calculated by CKD-EPI formula is less than 80 mL/min at screening
• Subjects showing clinically significant abnormalities on ECG at screening
• Allergy and drug abuse
• Subjects who are hypersensitive to the investigational product or its active ingredient and any other medications (aspirin, antibiotics etc.)
• Subjects with history of substance abuse or positive results from drug screening test.
• Contraindicated drugs/foods
• Subjects who have been taking any medications (including herbal medicines) or on an abnormal diet (ex: consuming more than 1L of grapefruit juice per day, large amounts of garlic, broccoli and kale, etc.) that can affect the absorption, distribution, metabolism and excretion of the IP within 28 days from the first IP administration date
• Subjects who took any prescription drugs(ETC) or any over-the-counter drugs(OTC) within 10 days from the first IP administration date

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

RECRUITING

Study Officials

• Jong Lyul Kim, MD, PhD

  Inje University

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: September 24, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 28, 2020

Record last verified: 2020-08

Locations

KR (1)