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

HK inno.N

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CJ-12420; Drug: Esomeprazole 40mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473173

CJ_APA_101

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 7 patient groups

CJ-12420 50mg

Experimental group

Description:

* Single dose * 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

CJ-12420 100mg

Experimental group

Description:

* Single dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

CJ-12420 200mg

Experimental group

Description:

* Single dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

CJ-12420 400mg

Experimental group

Description:

* Single dose * 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

CJ-12420 100mg (repeated dose)

Experimental group

Description:

Repeat doses * 100mg is the anticipated dose * 8 volunteers will be administered CJ-12420 100mg or placebo comparator.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

CJ-12420 200mg (repeated dose)

Experimental group

Description:

Repeat doses * 200mg is the anticipated dose * 8 volunteers will be administered CJ-12420 200mg or placebo comparator.(CJ-12420:placebo=6:2)

Treatment:

Drug: CJ-12420

Esomeprazole 40mg

Active Comparator group

Description:

8 volunteers will be administered Esomeprazole 40mg

Treatment:

Drug: Esomeprazole 40mg