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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01473173

Enrollment

Registered

2011-11-17

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2013-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics

Brief summary

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.

Interventions

DRUGCJ-12420

DRUGEsomeprazole 40mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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 * 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

Design outcomes

Primary

Measure	Time frame
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects	Throughout the study

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026