Clinical trial NCT01489774: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Digestive System Diseases
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 86
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of CJ-12406
timeFrame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Number of participants with adverse events
timeFrame: A range of 17 days - from screening to gollow-up visit
measure: Peak plasma concentration (Cmax) of CJ-12406
timeFrame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Area under the plasma concentration versus time curve (AUC) of active metabolite
timeFrame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
measure: Peak plasma concentration (Cmax) of active metabolite
timeFrame: 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose
Secondary outcomes:
measure: H. pylori eradication rate
timeFrame: 38 days post dose (plus of minus 1 day)
measure: The percent time of intragastric pH>4
timeFrame: 7 days post dose
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: