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

NCT01830309 | Completed Phase 1

• 1 other identifier: CJ_APA_102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Food-Effect; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

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

  Blood sampling during 24 or 48 hrs after administration

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

  Blood sampling during 24 or 48 hrs after administration

Secondary Outcomes (1)

• time pH > 4

  24 hour before and after IP administration

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: CJ-12420 200mg

Sequence 2

EXPERIMENTAL

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

Drug: CJ-12420 200mg

Interventions

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

Also known as: CJ-12420

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• mmHg ≤ systolic blood pressure ≤ 140 mmHg
• mmHg ≤ diastolic blood pressure ≤ 95 mmHg
• beats per minute ≤ pulse rate ≤ 95 beats per minute
• Understand the requirements of the study and voluntarily consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34246485 DERIVED

Study Officials

• Kyun-Seop Bae, MD, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 12, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

KR (1)