To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration

NCT03009760 | Completed Phase 1

• 1 other identifier: [CJ_APA_104]
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420 after single and multiple dose administration according to H. pylori infection.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration (Cmax) of CJ-12420

  up to 12 hours

Secondary Outcomes (6)

• Area under the plasma concentration versus time curve (AUC) of CJ-12420

  up to 12 hours

• Time of maximum observed concentration(tmax) of CJ-12420

  up to 12 hours

• Half life(t1/2β) of CJ-12420

  up to 12 hours

• Mean pH

  Day -1, Day 1, Day 7 up to 24 hours

• Time at pH > 4(%)

  Day -1, Day 1, Day 7 up to 24 hours

Study Arms (4)

CJ-12420 50mg(HP-)

EXPERIMENTAL

CJ-12420 50mg in H. pylori negative subject

Drug: CJ-12420 50mg(HP-)

CJ-12420 100mg(HP-)

EXPERIMENTAL

CJ-12420 100mg in H. pylori negative subject

Drug: CJ-12420 100mg(HP-)

CJ-12420 50mg(HP+)

EXPERIMENTAL

CJ-12420 50mg in H. pylori positive subject

Drug: CJ-12420 50mg(HP+)

CJ-12420 100mg(HP+)

EXPERIMENTAL

CJ-12420 100mg in H. pylori positive subject

Drug: CJ-12420 100mg(HP+)

Interventions

CJ-12420 50mg(HP+) DRUG

CJ-12420 50mg in H. pylori positive subject

Also known as: not yet determined

CJ-12420 50mg(HP+)

CJ-12420 100mg(HP+) DRUG

CJ-12420 100mg in H. pylori positive subject

Also known as: not yet determined

CJ-12420 100mg(HP+)

Eligibility Criteria

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

You may qualify if:

• Healthy male volunteers between 20 to 45 years of age (inclusive)
• Body mass index (BMI) in the range of 19\~28 kg/㎡ and weighted at least 50kg
• Medically healthy with no clinically significant vital signs (blood pressure in the sitting position, pulse rate)
• mmHg ≤ systolic blood pressure ≤ 140 mmHg
• mmHg ≤ diastolic blood pressure ≤ 95 mmHg
• beats per minute ≤ pulse rate ≤ 95 beats per minute
• Understood the requirements of the study and voluntarily consented to participate in the study
• Agreed to be sexually abstinent or to use a condom or spermicide when engaging in sexual activity and not to donate sperm during the course of the study for 30 days following completion of the study
• Non-smokers or non-users of nicotine-containing products for at least 1 year
• \[Cohort 1\] H. pylori negative as determined by urea breath test and serum IgG antibody
• \[Cohort 2\] H. pylori positive as determined by urea breath test and serum IgG

You may not qualify if:

• History of clinically significant gastrointestinal, renal, hepatic, neurologic, hemato-oncologic, endocrine, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition, which in the opinion of the investigators, would jeopardize the safety of the subject or impact the validity of the study results
• History of allergy or hypersensitivity to any drug, including prior serious adverse reaction to PPIs or P-CABs
• Undergone surgery or in a medical condition, which in the judgment of the PI or investigators may affect absorption, distribution, metabolism or elimination of the study drug
• Administered other drug(s) in other clinical study within 60 days prior to screening visit
• Donated blood within 60 days or blood components within 30 days, or had been transfused plasma within 30 days prior to screening visit
• On special diet or have experienced substantial changes in eating habits within 30 days prior to screening visit
• Used any prescription medication within 14 days, or any other OTC medications including herbal products within 7 days prior to screening visit
• Consumed over 21 units/week of alcohol
• Consumed over 5 units/day of caffeine-containing beverage
• Positive urine screen for drugs and/or cotinine
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
• Clinically significant abnormalities of liver function tests (≥1.5 fold of normal upper limit in the level of L-alanine aminotransferase (ALT), L-aspartate aminotransferase (AST) or total bilirubin)
• Unable to bear pH meter catheter insertion
• History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome
• Clinically significant observations considered as unsuitable based on medical judgment by investigators

Sponsors & Collaborators

• HK inno.N Corporation: lead
• Asan Medical Center: collaborator

Study Design

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

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share