Clinical trial NCT01830309: Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Official title: Clinical Study to Evaluate Food-Effect on Pharmacokinetics and Pharmacodynamics of Single Oral Dose of CJ-12420 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food-Effect
Pharmacokinetics
Pharmacodynamics
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Geometric mean ratio and 90% CI for log-transformed AUClast
timeFrame: Blood sampling during 24 or 48 hrs after administration
measure: Geometric mean ratio and 90% CI for log-transformed Cmax
timeFrame: Blood sampling during 24 or 48 hrs after administration
Secondary outcomes:
measure: time pH > 4
timeFrame: 24 hour before and after IP administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.