[KJ-INT-002] BE Study

NCT03509831 | Unknown Phase 1

• 1 other identifier: KJ-INT-002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects

Conditions

Gastritis

Outcome Measures

Primary Outcomes (2)

• AUCt

  Pharmacokinetic Characteristics

  One day

• Cmax

  Pharmacokinetic Characteristics

  One day

Secondary Outcomes (3)

• AUC∞

  One day

• tmax

  One day

• t1/2

  One day

Study Arms (2)

INT2150-A

OTHER

Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

INT2150-B

OTHER

Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

Interventions

INT-2150 DRUG

1. Period: INT-2150 2. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

INT2150-A; INT2150-B

Irsogladine maleate 2 mg+Nizatidine 150 mg DRUG

1. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg 2. Period: INT-2150

INT2150-A; INT2150-B

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
• Body weight \>= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m\^2 (inclusive).
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

You may not qualify if:

• Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
• Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.
• Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.
• Alanine aminotransferase, alkaline phosphatase \<=2x upper limit of normal (ULN) total bilirubin \> 2.0mg/dl and eGRF \<60mL/min/1.73m2
• History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>21 units for males. One unit is equivalent to 10 gram of alcohol.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).

Sponsors & Collaborators

• Kukje Pharma: lead

Study Sites (1)

Kukje Pharm

Seongnam-si, South Korea

Location

MeSH Terms

Conditions

Gastritis

Interventions

irsogladine; Nizatidine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sang-Heon Cho

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 26, 2018
• Study Start: November 2, 2017
• Primary Completion: January 24, 2018
• Study Completion: April 1, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

KR (1)