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Not yet recruiting NCT06736912

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

Phase I Interventional Chronic Idiopathic Constipation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IN-114199 2.5mg or placebo, IN-114199 10mg or placebo, IN-114199 20mg or placebo, IN-114199 40mg or placebo.
Who it may be relevant to
Registry conditions: Chronic Idiopathic Constipation. Basic parameters: 19 years — 63 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants

Overview

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

Interventions

  • Drug IN-114199 2.5mg or placebo
    IN-114199 2.5mg or placebo (1 Tablet, QD)
  • Drug IN-114199 10mg or placebo
    IN-114199 10mg or placebo (1 Tablet, QD)
  • Drug IN-114199 20mg or placebo
    IN-114199 10mg or placebo (2 Tablets, QD)
  • Drug IN-114199 40mg or placebo
    IN-114199 10mg or placebo (4 Tablets, QD)
  • Drug IN-114199 5mg or placebo
    IN-114199 2.5mg or placebo (2 Tablets, QD)

Primary outcome measures

  • Adverse Event [Time frame: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)]
  • Vital Sign [Time frame: Part I : Up to Day 3/ Part II: Up to Day 9]
  • Physical Examination [Time frame: Part I : Up to Day 3/ Part II: Up to Day 9]
  • Body Weight in kilograms Measurement [Time frame: Part I : Up to Day 3 / Part II: Up to Day 9]
  • 12-lead electrocardiogram (ECG) [Time frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9]
  • Clinical Laboratory Test [Time frame: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9]
Secondary outcome measures (4)
  • PK parameters (Urine and Plasma) [Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9]
  • PK parameters (Urine and Plasma) [Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9]
  • PD parameters (plasma C4 level) [Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9]
  • PD parameters (plasma LDL/HDL level) [Time frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8]

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.))
  • Subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Hospital, Clinical Trial Center — Seoul

Identifiers

NCT: NCT06736912 · IN_IBA_102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗