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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01473173
First received: November 14, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.

Condition Intervention Phase
Healthy
 Drug: CJ-12420
Drug: Esomeprazole 40mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study, to Investigate the Safety, Tolerability, PK and PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • To evaluate the PK, PD, safety and tolerability of escalating single and multiple oral doses of CJ-12420 in healthy male subjects [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CJ-12420 50mg
  • Single dose
  • 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)
 Drug: CJ-12420
-
Other Name: CJ-12420
Experimental: CJ-12420 100mg
  • Single dose
  • 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)
 Drug: CJ-12420
-
Other Name: CJ-12420
Experimental: CJ-12420 200mg
  • Single dose
  • 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)
 Drug: CJ-12420
-
Other Name: CJ-12420
Experimental: CJ-12420 400mg
  • Single dose
  • 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)
 Drug: CJ-12420
-
Other Name: CJ-12420
Experimental: CJ-12420 100mg (repeated dose)

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
-
Other Name: CJ-12420
Experimental: CJ-12420 200mg (repeated dose)

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
-
Other Name: CJ-12420
Active Comparator: Esomeprazole 40mg
8 volunteers will be administered Esomeprazole 40mg
 Drug: Esomeprazole 40mg
-
Other Name: Nexium

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473173

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ Cheiljedang Corporation
Investigators
Principal Investigator: Kyun-Seop Bae, MD, Ph.D Asan Medical Center
  More Information

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01473173     History of Changes
Other Study ID Numbers: CJ_APA_101
Study First Received: November 14, 2011
Last Updated: April 9, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CJ Cheiljedang Corporation:
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013