Digestive System Diseases
Conditions
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.
Interventions
DRUGPlacebo
single and multiple dose
DRUGCJ-12406
single and multiple dose
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | A range of 17 days - from screening to gollow-up visit | — |
| Area under the plasma concentration versus time curve (AUC) of active metabolite | 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 | 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 CJ-12406 | 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 CJ-12406 | 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
| Measure | Time frame | Description |
|---|---|---|
| The percent time of intragastric pH>4 | 7 days post dose | — |
| H. pylori eradication rate | 38 days post dose (plus of minus 1 day) | UBT test |
Countries
South Korea
Outcome results
None listed