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

Launched by HK INNO.N CORPORATION · Dec 15, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to study a new medication called IN-114199, which is being tested for its safety and how well it works in healthy adults. The main goal is to see how the drug moves through the body and how food affects its performance. The study is focused on people who experience chronic idiopathic constipation, a condition where a person has difficulty passing stools without a known cause.

To be eligible for this trial, participants must be healthy adults between the ages of 19 and 63, and they should have regular bowel movements almost every day for at least six months. They also need to meet certain health criteria, such as having a body weight between 40 to 100 kg and a specific body mass index. Participants will undergo various tests to ensure they are suitable for the study and will need to provide written consent before joining. The trial is not yet recruiting participants, but those who take part can expect to be closely monitored for their health and safety throughout the study.

Gender

ALL

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.