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

NCT ID: NCT01830309

Last Updated: 2013-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-02-28

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence 1

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

Group Type: EXPERIMENTAL

CJ-12420 200mg

Intervention Type: 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

Sequence 2

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

Group Type: EXPERIMENTAL

CJ-12420 200mg

Intervention Type: 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

Interventions

CJ-12420 200mg

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

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

Intervention Type: DRUG

Other Intervention Names

CJ-12420

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyun-Seop Bae, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Han S, Choi HY, Kim YH, Nam JY, Kim B, Song GS, Lim HS, Bae KS. Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of Tegoprazan. Clin Ther. 2021 Aug;43(8):1371-1380. doi: 10.1016/j.clinthera.2021.06.007. Epub 2021 Jul 8.

Reference Type: DERIVED

PMID: 34246485 (View on PubMed)

Other Identifiers

CJ_APA_102

Identifier Type: -

Identifier Source: org_study_id