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Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

NCT ID: NCT01489774

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-06-30

Brief Summary

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Study objectives

* To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
* To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
* To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.

Detailed Description

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Conditions

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Digestive System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single and multiple dose

CJ-12406

CJ-12406 Tablet, daily for 1 day or bid for 10 days

Group Type EXPERIMENTAL

CJ-12406

Intervention Type DRUG

single and multiple dose

Interventions

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Placebo

single and multiple dose

Intervention Type DRUG

CJ-12406

single and multiple dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male volunteers in the age between 20 and 45 years old
2. Subjects with no history of any significant chronic disease
3. The weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
5. Available for the entire study period
6. Willing to adhere to protocol requirements and sign a informed consent form
7. Multiple escalation study; H. pylori positive, as determined by the urea breath test

Exclusion Criteria

1. History of clinically significant allergies including drug allergies
2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
3. Symptom of an acute illness within 4 weeks prior to drug administration
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
6. Clinical laboratory test values are outside the accepted normal range

* AST or ALT \>1.25 times to normal range
* Creatinine clearance \<80 mL/min
* 12-lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec
7. Clinically significant vital signs

* Hypotension (SBP ≤ 89 mmHg)
* Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
* Tachycardia (≥ 101 beats/min)
8. History of drug and alcohol abuse(alcohol \> 30 g/day)
9. Subjects who have ever smoke within 3 months prior to drug administration
10. Positive urine screen for drugs and cotinine
11. Use of any other medication, including herbal products, within the 2 weeks before dosing
12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
13. Donated blood within 60 days prior to dosing
14. Participated in a previous clinical trial within 90 days prior to dosing
15. Subjects considered as unsuitable based on medical judgement by investigators
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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HK inno.N Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae-Gook Shin, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_HET_101

Identifier Type: -

Identifier Source: org_study_id