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Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01830309
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
1
Duration (Months)
23.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  • Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.

  • Secondary

  • To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)

  • To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.

Condition or Disease Intervention/Treatment Phase
  • Drug: CJ-12420 200mg
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence 1

Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition

Drug: CJ-12420 200mg
Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
Other Names:
  • CJ-12420

    		•
    Experimental: Sequence 2

    Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition

    Drug: CJ-12420 200mg
    Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition
    Other Names:
  • CJ-12420

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geometric mean ratio and 90% CI for log-transformed AUClast [Blood sampling during 24 or 48 hrs after administration]

    2. Geometric mean ratio and 90% CI for log-transformed Cmax [Blood sampling during 24 or 48 hrs after administration]

    Secondary Outcome Measures

    1. time pH > 4 [24 hour before and after IP administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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 (inclusive)

    • Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate)

    1. 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg

    2. 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg

    3. 45 beats per minute ≤ pulse rate ≤ 95 beats per minute

    • Understand the requirements of the study and voluntarily consent to participate in the study
    Exclusion Criteria:

    Subjects will be excluded from the study if there is evidence of any of the following criteria: Last three criteria will be applied ONLY to PD/PK group.

    • 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

    The following criteria will be applied ONLY to PD/PK group

    • H.pylori positive, as determined by the urea breath test

    • Urine cotinine test positive

    • Subject who were unable to be applicable for pH meter catheter

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: Kyun-Seop Bae, MD, Ph.D, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT01830309
    Other Study ID Numbers:
    • CJ_APA_102
    First Posted:
    Apr 12, 2013
    Last Update Posted:
    Apr 12, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by HK inno.N Corporation
    Food-Effect
    Pharmacokinetics
    Pharmacodynamics

    Study Results

    No Results Posted as of Apr 12, 2013