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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Digestive System Diseases
- Sponsor
- HK inno.N Corporation
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC) of CJ-12406
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo
Intervention: Placebo
CJ-12406
CJ-12406 Tablet, daily for 1 day or bid for 10 days
Intervention: CJ-12406
Outcomes
Primary Outcomes
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
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
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
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
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
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 Outcomes
- H. pylori eradication rate(38 days post dose (plus of minus 1 day))
- The percent time of intragastric pH>4(7 days post dose)