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

HK inno.N

Status and phase: Not yet enrolling; Phase 1

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: IN-114199 40mg or placebo; Drug: IN-114199 5mg or placebo; Drug: IN-114199 20mg or placebo; Drug: IN-114199 2.5mg or placebo; Drug: IN-114199 10mg or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06736912

IN_IBA_102

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 63 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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80 participants in 9 patient groups

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

Experimental group

Description:

SAD

Treatment:

Drug: IN-114199 2.5mg or placebo

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

Experimental group

Description:

SAD and FES

Treatment:

Drug: IN-114199 5mg or placebo

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

Experimental group

Description:

SAD and FES

Treatment:

Drug: IN-114199 10mg or placebo

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

Experimental group

Description:

SAD and FES

Treatment:

Drug: IN-114199 20mg or placebo

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

Experimental group

Description:

SAD

Treatment:

Drug: IN-114199 40mg or placebo

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

Experimental group

Description:

MAD

Treatment:

Drug: IN-114199 2.5mg or placebo

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

Experimental group

Description:

MAD

Treatment:

Drug: IN-114199 5mg or placebo

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

Experimental group

Description:

MAD

Treatment:

Drug: IN-114199 10mg or placebo

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

Experimental group

Description:

MAD

Treatment:

Drug: IN-114199 20mg or placebo