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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-12420 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830309

CJ_APA_102

Details and patient eligibility

About

• 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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: CJ-12420 200mg

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: CJ-12420 200mg