Pharmacodynamic Properties of CJ-12420 on Evening Dosing

NCT03043521 | Completed Phase 1

• 1 other identifier: CJ_APA_105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Time pH > 4 of CJ-12420

  intragastric pH

  24 hours pH

Secondary Outcomes (7)

• Cmax of CJ-12420

  up to 20 hours

• AUClast of CJ-12420

  up to 20 hours

• Cmax of dexlansoprazole

  up to 20 hours

• AUClast of dexlansoprazole

  up to 20 hours

• Time pH > 4 of dexlansoprazole

  24 hours pH

Study Arms (4)

CJ-12420 50mg

EXPERIMENTAL

T1=CJ-12420 50mg QD evening (9PM)

Drug: CJ-12420 50mg

CJ-12420 100mg

EXPERIMENTAL

T2=CJ-12420 100mg QD evening (9PM)

Drug: CJ-12420 100mg

CJ-12420 200mg

EXPERIMENTAL

T3=CJ-12420 200mg QD evening (9PM)

Drug: CJ-12420 200mg

Dexlansopazole 60mg

ACTIVE COMPARATOR

R=dexlansoprazole 60mg QD evening (9p.m)

Drug: Dexlansoprazole 60 MG

Interventions

Dexlansoprazole 60 MG DRUG

Also known as: R

Dexlansopazole 60mg

CJ-12420 50mg DRUG

Also known as: T1

CJ-12420 50mg

CJ-12420 100mg DRUG

Also known as: T2

CJ-12420 100mg

CJ-12420 200mg DRUG

Also known as: T3

CJ-12420 200mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Healthy male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers aged ≥20 to ≤45 years
• Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg
• Medically healthy without clinically significant vital signs (blood pressure in sitting position, heart rate)
• mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg
• mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg
• (beats/min) ≤ Heart rate ≤ 95 (beats/min)
• Understand restriction during the study and voluntarily consent to participate in the study
• 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
• Non-smoker or ex-smoker who stopped smoking for at least one year
• Negative H. pylori result in urea breath test (UBT)

You may not qualify if:

• 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
• History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB
• 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
• History of use of another investigational product within 90 days prior to screening visit
• Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit
• Having special diet or changes in dietary habits within 30 days prior to screening visit
• Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit
• Alcohol \> 21 units/week
• Caffeinated drink intake \> 5units/day
• Positive on urinary drug screening test or urine nicotine test
• Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test
• Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))
• Inability to tolerate pH catheter insertion
• History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome
• Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Dexlansoprazole; Triiodothyronine

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Eunji Kim

  CJ HealthCare Corp.

  STUDY DIRECTOR

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: January 19, 2017
• First Posted: February 6, 2017
• Study Start: May 13, 2015
• Primary Completion: August 12, 2015
• Study Completion: August 12, 2015
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)