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

NCT01473173 | Completed Phase 1

• 1 other identifier: CJ_APA_101
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (7)

CJ-12420 50mg

EXPERIMENTAL

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

Drug: CJ-12420

CJ-12420 100mg

EXPERIMENTAL

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

Drug: CJ-12420

CJ-12420 200mg

EXPERIMENTAL

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

Drug: CJ-12420

CJ-12420 400mg

EXPERIMENTAL

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

Drug: CJ-12420

CJ-12420 100mg (repeated dose)

EXPERIMENTAL

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

Drug: CJ-12420

CJ-12420 200mg (repeated dose)

EXPERIMENTAL

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

Drug: CJ-12420

Esomeprazole 40mg

ACTIVE COMPARATOR

8 volunteers will be administered Esomeprazole 40mg

Drug: Esomeprazole 40mg

Interventions

CJ-12420 DRUG

CJ-12420 100mg; CJ-12420 100mg (repeated dose); CJ-12420 200mg; CJ-12420 200mg (repeated dose); CJ-12420 400mg; CJ-12420 50mg

Esomeprazole 40mg DRUG

Also known as: Nexium

Esomeprazole 40mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kyun-Seop Bae, MD, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

KR (1)