Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing

The purpose of this study is to compare and evaluate impact on pharmacodynamic characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CJ-12420 50mg; Drug: CJ-12420 100mg; Drug: CJ-12420 200mg; Drug: Dexlansoprazole 60 MG

Detailed Description

Evaluation Criteria:

1. Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420
2. Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH
3. Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate, body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male volunteers aged ≥20 to ≤45 years
2. Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg

3. Medically healthy without clinically significant vital signs (blood pressure in sitting position, heart rate)

   • 90 mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg
   • 50 mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg
   • 45 (beats/min) ≤ Heart rate ≤ 95 (beats/min)
4. Understand restriction during the study and voluntarily consent to participate in the study
5. Consent to use the effective contraceptive methods (using abstinence, spermicide, and condom) and not to donate sperm during the study and until 30 days after completion of study
6. Non-smoker or ex-smoker who stopped smoking for at least one year
7. Negative H. pylori result in urea breath test (UBT)

Exclusion Criteria:

1. History of clinically significant diseases in the digestive, kidney, liver, nervous, hemato-oncologic, endocrine, respiratory, immune, psychiatric, musculoskeletal, or cardiovascular system and other diseases that may harm safety of the subject or may affect the validity of study results, in the judgment of investigator
2. History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB
3. History surgery that may affect absorption, distribution, metabolism, and elimination of the study drug or in such a medical condition, at the discretion of the principal investigator or sub-investigator
4. History of use of another investigational product within 90 days prior to screening visit
5. Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit
6. Having special diet or changes in dietary habits within 30 days prior to screening visit
7. Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit
8. Alcohol > 21 units/week
9. Caffeinated drink intake > 5units/day
10. Positive on urinary drug screening test or urine nicotine test
11. Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test
12. Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))
13. Inability to tolerate pH catheter insertion
14. History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome
15. Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CJ-12420 50mg; T1=CJ-12420 50mg QD evening (9PM)	Drug: CJ-12420 50mg; Other Names: T1
Experimental: CJ-12420 100mg; T2=CJ-12420 100mg QD evening (9PM)	Drug: CJ-12420 100mg; Other Names: T2
Experimental: CJ-12420 200mg; T3=CJ-12420 200mg QD evening (9PM)	Drug: CJ-12420 200mg; Other Names: T3
Active Comparator: Dexlansopazole 60mg; R=dexlansoprazole 60mg QD evening (9p.m)	Drug: Dexlansoprazole 60 MG; Other Names: R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time pH > 4 of CJ-12420	intragastric pH	24 hours pH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of CJ-12420	maximum measured plasma concentraion	up to 20 hours
AUClast of CJ-12420	The area under the plasma concentration versus time curve from time 0 to the last measurable concentration	up to 20 hours
Cmax of dexlansoprazole	maximum measured plasma concentraion	up to 20 hours
AUClast of dexlansoprazole	The area under the plasma concentration versus time curve from time 0 to the last measurable concentration	up to 20 hours
Time pH > 4 of dexlansoprazole	intragastric pH	24 hours pH
Median pH > 4 of CJ-12420	intragastric pH	24 hours pH
Median pH > 4 of dexlansoprazole	intragastric pH	24 hours pH

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Study Director: Eunji Kim, CJ HealthCare Corp.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2015
• Primary Completion (Actual): August 12, 2015
• Study Completion (Actual): August 12, 2015

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: CJ_APA_105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No