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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Digestive System Diseases

Treatments: Drug: Placebo; Drug: CJ-12406

Study type: Interventional

Funder types: Industry

Identifiers

NCT01489774

CJ_HET_101

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

86 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CJ-12406

Experimental group

Description:

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

Treatment:

Drug: CJ-12406