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
- Phase
- Phase 1
- Intervention
- IN-114199 2.5mg or placebo
- Conditions
- Chronic Idiopathic Constipation
- Sponsor
- HK inno.N Corporation
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Adverse Event
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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
Investigators
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
Arms & Interventions
Part I(Cohort I) IN-114199 2.5 mg or Placebo
SAD
Intervention: IN-114199 2.5mg or placebo
Part I(Cohort 2) IN-114199 5 mg or Placebo
SAD and FES
Intervention: IN-114199 5mg or placebo
Part I(Cohort 3) IN-114199 10 mg or Placebo
SAD and FES
Intervention: IN-114199 10mg or placebo
Part I(Cohort 4) IN-114199 20 mg or Placebo
SAD and FES
Intervention: IN-114199 20mg or placebo
Part I(Cohort 5) IN-114199 40 mg or Placebo
SAD
Intervention: IN-114199 40mg or placebo
Part II(Cohort I) IN-114199 2.5 mg or Placebo
MAD
Intervention: IN-114199 2.5mg or placebo
Part II(Cohort 2) IN-114199 5 mg or Placebo
MAD
Intervention: IN-114199 5mg or placebo
Part II(Cohort 3) IN-114199 10 mg or Placebo
MAD
Intervention: IN-114199 10mg or placebo
Part II(Cohort 4) IN-114199 20 mg or Placebo
MAD
Intervention: IN-114199 20mg or placebo
Outcomes
Primary Outcomes
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)
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Vital Sign
Time Frame: Part I : Up to Day 3/ Part II: Up to Day 9
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Physical Examination
Time Frame: Part I : Up to Day 3/ Part II: Up to Day 9
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Body Weight in kilograms Measurement
Time Frame: Part I : Up to Day 3 / Part II: Up to Day 9
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
12-lead electrocardiogram (ECG)
Time Frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9
QT/QTc interval will be recorded and analyzed automatically.
Clinical Laboratory Test
Time Frame: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Secondary Outcomes
- PK parameters (Urine and Plasma)(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)(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)(Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8)