Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CJ-12420; Drug: Esomeprazole 40mg

• Registration Number: NCT01473173
• Lead Sponsor: HK inno.N Corporation

Brief Summary

The objectives of this study are:

* To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.

* To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.

* To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.

* To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

Inclusion Criteria

• Male volunteers in the age between 20 and 45 years old (inclusive)
• Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
• Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg, 45 beats per minute ≤ pulse rate ≤ 95 beats per minute)
• Non-smokers or non-users of nicotine-containing products for at least 3 months

Exclusion Criteria

• History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
• History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
• History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CJ-12420 200mg	CJ-12420	* Single dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)
Esomeprazole 40mg	Esomeprazole 40mg	8 volunteers will be administered Esomeprazole 40mg
CJ-12420 50mg	CJ-12420	* Single dose * 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)
CJ-12420 100mg	CJ-12420	* Single dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)
CJ-12420 400mg	CJ-12420	* Single dose * 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)
CJ-12420 100mg (repeated dose)	CJ-12420	Repeat doses * 100mg is the anticipated dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2)
CJ-12420 200mg (repeated dose)	CJ-12420	Repeat doses * 200mg is the anticipated dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2)

Primary Outcome Measures

Name	Time	Method
To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects	Throughout the study

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of