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OpenTrials
Completed

NCT Number: NCT01473173

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

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.

Completed

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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
  • 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

Treatment and study plan

CJ-12420

Drug

Esomeprazole 40mg

Drug

Other names: Nexium

Primary outcomes

  1. To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2011
Registry last updated
Apr 10, 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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