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Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

NCT ID: NCT01473173

Last Updated: 2013-04-10

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-08-31

Brief Summary

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The objectives of this study are:

* To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
* To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CJ-12420 50mg

* Single dose
* 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

CJ-12420 100mg

* Single dose
* 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

CJ-12420 200mg

* Single dose
* 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

CJ-12420 400mg

* Single dose
* 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

CJ-12420 100mg (repeated dose)

Repeat doses

* 100mg is the anticipated dose
* 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

CJ-12420 200mg (repeated dose)

Repeat doses

* 200mg is the anticipated dose
* 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2)

Group Type EXPERIMENTAL

CJ-12420

Intervention Type DRUG

Esomeprazole 40mg

8 volunteers will be administered Esomeprazole 40mg

Group Type ACTIVE_COMPARATOR

Esomeprazole 40mg

Intervention Type DRUG

Interventions

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CJ-12420

Intervention Type DRUG

Esomeprazole 40mg

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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Inclusion Criteria

* Male volunteers in the age between 20 and 45 years old (inclusive)
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
* Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg, 45 beats per minute ≤ pulse rate ≤ 95 beats per minute)
* Non-smokers or non-users of nicotine-containing products for at least 3 months

Exclusion Criteria

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
* History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
* History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
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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Kyun-Seop Bae, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CJ_APA_101

Identifier Type: -

Identifier Source: org_study_id

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