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

Phase 1

Completed

• Conditions: Digestive System Diseases
• Interventions: Drug: Placebo; Drug: CJ-12406

• Registration Number: NCT01489774
• Lead Sponsor: HK inno.N Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
CJ-12406	CJ-12406	CJ-12406 Tablet, daily for 1 day or bid for 10 days

Primary Outcome Measures

Name	Time	Method
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.
Number of participants with adverse events	A range of 17 days - from screening to gollow-up visit
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.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of