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Completed

NCT Number: NCT01830309

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

* 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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • 90 mmHg ≤ systolic blood pressure ≤ 140 mmHg
  • 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg
  • 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

Treatment and study plan

CJ-12420 200mg

Drug

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

Primary outcomes

  1. Geometric mean ratio and 90% CI for log-transformed AUClast

    Time frame: Blood sampling during 24 or 48 hrs after administration

  2. Geometric mean ratio and 90% CI for log-transformed Cmax

    Time frame: Blood sampling during 24 or 48 hrs after administration

Secondary outcomes

  1. time pH > 4

    Time frame: 24 hour before and after IP administration

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 12, 2013
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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