- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509831
[KJ-INT-002] BE Study
April 17, 2018 updated by: Kukje Pharma
A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects
Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seongnam-si, Korea, Republic of
- Kukje Pharm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: INT2150-A
|
|
OTHER: INT2150-B
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt
Time Frame: One day
|
Pharmacokinetic Characteristics
|
One day
|
Cmax
Time Frame: One day
|
Pharmacokinetic Characteristics
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC∞
Time Frame: One day
|
Pharmacokinetic Characteristics
|
One day
|
tmax
Time Frame: One day
|
Pharmacokinetic Characteristics
|
One day
|
t1/2
Time Frame: One day
|
Pharmacokinetic Characteristics
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 2, 2017
Primary Completion (ACTUAL)
January 24, 2018
Study Completion (ANTICIPATED)
April 1, 2018
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 17, 2018
First Posted (ACTUAL)
April 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 17, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Gastritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Gastrointestinal Agents
- Protective Agents
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Anticarcinogenic Agents
- Radiation-Protective Agents
- Histamine H2 Antagonists
- Nizatidine
- Irsogladine
Other Study ID Numbers
- KJ-INT-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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