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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ-12420 200mg

• Registration Number: NCT01830309
• Lead Sponsor: HK inno.N Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-03-29
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	CJ-12420 200mg	Drug: CJ-12420 200mg Period1: CJ-12420 under fasting condition Period2: CJ-12420 under fed condition
Sequence 1	CJ-12420 200mg	Drug: CJ-12420 200mg Period1: CJ-12420 under fed condition Period2: CJ-12420 under fasting condition

Primary Outcome Measures

Name	Time	Method
Geometric mean ratio and 90% CI for log-transformed AUClast	Blood sampling during 24 or 48 hrs after administration
Geometric mean ratio and 90% CI for log-transformed Cmax	Blood sampling during 24 or 48 hrs after administration

Secondary Outcome Measures

Name	Time	Method
time pH > 4	24 hour before and after IP administration

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of