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

Primary Purpose

Digestive System Diseases

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
CJ-12406
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Digestive System Diseases

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Inje University Busan Paik Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

CJ-12406

Arm Description

CJ-12406 Tablet, daily for 1 day or bid for 10 days

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of CJ-12406
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
Peak plasma concentration (Cmax) of CJ-12406
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
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
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
UBT test
The percent time of intragastric pH>4

Full Information

First Posted
November 9, 2011
Last Updated
August 1, 2012
Sponsor
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01489774
Brief Title
Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CJ-12406
Arm Type
Experimental
Arm Description
CJ-12406 Tablet, daily for 1 day or bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single and multiple dose
Intervention Type
Drug
Intervention Name(s)
CJ-12406
Intervention Description
single and multiple dose
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of CJ-12406
Description
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.
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
Title
Number of participants with adverse events
Time Frame
A range of 17 days - from screening to gollow-up visit
Title
Peak plasma concentration (Cmax) of CJ-12406
Description
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.
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
Title
Area under the plasma concentration versus time curve (AUC) of active metabolite
Description
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.
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
Title
Peak plasma concentration (Cmax) of active metabolite
Description
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.
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
Secondary Outcome Measure Information:
Title
H. pylori eradication rate
Description
UBT test
Time Frame
38 days post dose (plus of minus 1 day)
Title
The percent time of intragastric pH>4
Time Frame
7 days post dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male volunteers in the age between 20 and 45 years old Subjects with no history of any significant chronic disease The weight range is not exceed ±20% of ideal weight. Ideal weight = [height -100]*0.9 Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data Available for the entire study period Willing to adhere to protocol requirements and sign a informed consent form Multiple escalation study; H. pylori positive, as determined by the urea breath test Exclusion Criteria: History of clinically significant allergies including drug allergies History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease Symptom of an acute illness within 4 weeks prior to drug administration History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration 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 Clinically significant vital signs Hypotension (SBP ≤ 89 mmHg) Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg) Tachycardia (≥ 101 beats/min) History of drug and alcohol abuse(alcohol > 30 g/day) Subjects who have ever smoke within 3 months prior to drug administration Positive urine screen for drugs and cotinine Use of any other medication, including herbal products, within the 2 weeks before dosing 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 Donated blood within 60 days prior to dosing Participated in a previous clinical trial within 90 days prior to dosing Subjects considered as unsuitable based on medical judgement by investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Gook Shin, MD. PhD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of

12. IPD Sharing Statement

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

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