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

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 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.

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases
• Intervention / Treatment: Drug: Placebo; Drug: CJ-12406

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • Inje University Busan Paik Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Number of participants with adverse events		A range of 17 days - from screening to gollow-up visit
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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rate	UBT test	38 days post dose (plus of minus 1 day)
The percent time of intragastric pH>4		7 days post dose

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Jae-Gook Shin, MD. PhD, Inje University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: December 8, 2011
• First Posted (Estimate): December 12, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2012
• Last Update Submitted That Met QC Criteria: August 1, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: CJ_HET_101