This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants

NCT ID: NCT06736912

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2025-11-11

Brief Summary

This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants

Detailed Description

Part A: SAD and FES study

• To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults
• To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults

Part B: MAD study

• To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults

Conditions

Chronic Idiopathic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part I(Cohort I) IN-114199 2.5 mg or Placebo

SAD

Group Type: EXPERIMENTAL

IN-114199 2.5mg or placebo

Intervention Type: DRUG

IN-114199 2.5mg or placebo (1 Tablet, QD)

Part I(Cohort 2) IN-114199 5 mg or Placebo

SAD and FES

Group Type: EXPERIMENTAL

IN-114199 5mg or placebo

Intervention Type: DRUG

IN-114199 2.5mg or placebo (2 Tablets, QD)

Part I(Cohort 3) IN-114199 10 mg or Placebo

SAD and FES

Group Type: EXPERIMENTAL

IN-114199 10mg or placebo

Intervention Type: DRUG

IN-114199 10mg or placebo (1 Tablet, QD)

Part I(Cohort 4) IN-114199 20 mg or Placebo

SAD and FES

Group Type: EXPERIMENTAL

IN-114199 20mg or placebo

Intervention Type: DRUG

IN-114199 10mg or placebo (2 Tablets, QD)

Part I(Cohort 5) IN-114199 40 mg or Placebo

SAD

Group Type: EXPERIMENTAL

IN-114199 40mg or placebo

Intervention Type: DRUG

IN-114199 10mg or placebo (4 Tablets, QD)

Part II(Cohort I) IN-114199 2.5 mg or Placebo

MAD

Group Type: EXPERIMENTAL

IN-114199 2.5mg or placebo

Intervention Type: DRUG

IN-114199 2.5mg or placebo (1 Tablet, QD)

Part II(Cohort 2) IN-114199 5 mg or Placebo

MAD

Group Type: EXPERIMENTAL

IN-114199 5mg or placebo

Intervention Type: DRUG

IN-114199 2.5mg or placebo (2 Tablets, QD)

Part II(Cohort 3) IN-114199 10 mg or Placebo

MAD

Group Type: EXPERIMENTAL

IN-114199 10mg or placebo

Intervention Type: DRUG

IN-114199 10mg or placebo (1 Tablet, QD)

Part II(Cohort 4) IN-114199 20 mg or Placebo

MAD

Group Type: EXPERIMENTAL

IN-114199 20mg or placebo

Intervention Type: DRUG

IN-114199 10mg or placebo (2 Tablets, QD)

Interventions

IN-114199 2.5mg or placebo

IN-114199 2.5mg or placebo (1 Tablet, QD)

Intervention Type: DRUG

IN-114199 10mg or placebo

IN-114199 10mg or placebo (1 Tablet, QD)

Intervention Type: DRUG

IN-114199 20mg or placebo

IN-114199 10mg or placebo (2 Tablets, QD)

Intervention Type: DRUG

IN-114199 40mg or placebo

IN-114199 10mg or placebo (4 Tablets, QD)

Intervention Type: DRUG

IN-114199 5mg or placebo

IN-114199 2.5mg or placebo (2 Tablets, QD)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent
• Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months
• Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
• Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
• Those who are judged eligible for this study upon judgment of the investigator in screening tests established depending on the characteristics of investigational product (examinations by interview, clinical laboratory test, physical examinations, etc.).

Exclusion Criteria

• Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
• Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
• Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
• Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• Subjects who have history of drug abuse, or who have a positive urine test for drugs of abuse.
• Blood AST(SGOT), and ALT(SGPT) > 60 IU/L at the screening test
• Showing the following findings on ECG at the screening test: QT > 480 msec(all), QTcB>450(male), QTcB>470(female)
• Subjects who have taken any drugs known to significantly induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 1 month prior to the expected initial application date.
• Subjects who have participated in other clinical trials within 6 months prior to the expected initial application date
• Subjects who have history of regular alcohol consumption exceeding 21 units/week (1 unit = 10 g = 12.5 mL of pure alcohol) or subjects who cannot avoid drinking alcohol from 3 days prior to the expected initial application date to the discharge
• Subjects who have history of average use of 10 cigarettes daily
• Subjects who consumed caffeine-containing food (coffee, green tea, black tea, carbonated beverage, coffee-flavored milk, tonics, etc.) or subjects who cannot avoid drinking caffeine-containing food from 3 days prior to the expected initial application date to the discharge
• Subjects are unable to use a highly effective method of contraception (e.g., correctly placed intrauterine device(IUD), sterilization surgery (vasectomy, tubal ligation, etc.))

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital, Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Central Contacts

Seung Hee Jung, Ph.D

Role: CONTACT

Phone: +82-2-6477-0164

Email: shee.jung@inno-n.com

Eun Ji Kim

Role: CONTACT

Phone: +82-2-6477-0290

Email: eunji.kim24@inno-n.com

Facility Contacts

Seung Hwan Lee, MD, PhD

Role: primary

Other Identifiers

IN_IBA_102

Identifier Type: -

Identifier Source: org_study_id