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

Digestive System Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489774
• Other study ID #: CJ_HET_101
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2011
• Last updated: August 1, 2012
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• Placebo
single and multiple dose
• CJ-12406
single and multiple dose

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of CJ-12406	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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose	No
Primary	Number of participants with adverse events		A range of 17 days - from screening to gollow-up visit	Yes
Primary	Peak plasma concentration (Cmax) of CJ-12406	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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose	No
Primary	Area under the plasma concentration versus time curve (AUC) of active metabolite	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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose	No
Primary	Peak plasma concentration (Cmax) of active metabolite	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.	0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose	No
Secondary	H. pylori eradication rate	UBT test	38 days post dose (plus of minus 1 day)	No
Secondary	The percent time of intragastric pH>4		7 days post dose	No