Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ HealthCare Corporation
ClinicalTrials.gov Identifier:
NCT01489774
First received: November 9, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Study objectives

  • To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
  • To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
  • To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.

Condition Intervention Phase
Digestive System Diseases
Drug: Placebo
Drug: CJ-12406
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dose, Dose-escalation Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 After Oral Administration in Healthy Male Subjects, Phase I Study

Resource links provided by NLM:


Further study details as provided by CJ HealthCare Corporation:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of CJ-12406 [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
    Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  • Number of participants with adverse events [ Time Frame: A range of 17 days - from screening to gollow-up visit ] [ Designated as safety issue: Yes ]
  • Peak plasma concentration (Cmax) of CJ-12406 [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
    Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  • Area under the plasma concentration versus time curve (AUC) of active metabolite [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
    Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.

  • Peak plasma concentration (Cmax) of active metabolite [ Time Frame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose ] [ Designated as safety issue: No ]
    Blood samples were collected before dosing and 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose (multiple dose study; 1 and 10 day). For multiple dose study, additional blood samples will be drawn predose (immediately prior to morning dosing) on days 3, 7, and 9.


Secondary Outcome Measures:
  • H. pylori eradication rate [ Time Frame: 38 days post dose (plus of minus 1 day) ] [ Designated as safety issue: No ]
    UBT test

  • The percent time of intragastric pH>4 [ Time Frame: 7 days post dose ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
single and multiple dose
Experimental: CJ-12406
CJ-12406 Tablet, daily for 1 day or bid for 10 days
Drug: CJ-12406
single and multiple dose

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male volunteers in the age between 20 and 45 years old
  2. Subjects with no history of any significant chronic disease
  3. The weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9
  4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
  5. Available for the entire study period
  6. Willing to adhere to protocol requirements and sign a informed consent form
  7. Multiple escalation study; H. pylori positive, as determined by the urea breath test

Exclusion Criteria:

  1. History of clinically significant allergies including drug allergies
  2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
  3. Symptom of an acute illness within 4 weeks prior to drug administration
  4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
  5. Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
  6. Clinical laboratory test values are outside the accepted normal range

    • AST or ALT >1.25 times to normal range
    • Creatinine clearance <80 mL/min
    • 12-lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec
  7. Clinically significant vital signs

    • Hypotension (SBP ≤ 89 mmHg)
    • Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
    • Tachycardia (≥ 101 beats/min)
  8. History of drug and alcohol abuse(alcohol > 30 g/day)
  9. Subjects who have ever smoke within 3 months prior to drug administration
  10. Positive urine screen for drugs and cotinine
  11. Use of any other medication, including herbal products, within the 2 weeks before dosing
  12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
  13. Donated blood within 60 days prior to dosing
  14. Participated in a previous clinical trial within 90 days prior to dosing
  15. Subjects considered as unsuitable based on medical judgement by investigators
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489774

Locations
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
CJ HealthCare Corporation
Investigators
Principal Investigator: Jae-Gook Shin, MD. PhD Inje University
  More Information

No publications provided

Responsible Party: CJ HealthCare Corporation
ClinicalTrials.gov Identifier: NCT01489774     History of Changes
Other Study ID Numbers: CJ_HET_101
Study First Received: November 9, 2011
Last Updated: August 1, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014