Phase I Study on Multiple Oral Dosing of CG100649

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

Detailed Description
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Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

Official Title
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A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CG100649
* Drug: Placebo
* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of known hypersensitivity to drugs including CG100649. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG100649<br>By the amount of doses, the groups are classified | Drug: CG100649<br>* 6 subjects: study drug 2 subjects: placebo<br>Drug: Placebo<br>* 6 subjects: study drug 2 subjects: placebo<br>|
| Active Comparator: Naproxen<br>By the amount of doses, the groups are classified | Drug: Placebo<br>* 6 subjects: study drug 2 subjects: placebo<br>Drug: Naproxen<br>* 6 subjects: study drug 2 subjects: placebo<br>* Other names: NAXEN;|
| Placebo Comparator: Placebo<br>By the amount of doses, the groups are classified | Drug: Placebo<br>* 6 subjects: study drug 2 subjects: placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (normal results for safety tests) | Cardiovascular: BP,ECG, Holter monitoring GI: Fecal occult blood Kidney: Urine electrolyte test Adverse events Physical examination, vital signs | 27days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers