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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

November 14, 2011
April 9, 2013
November 2011
August 2012   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT01473173 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: CJ-12420
    -
    Other Name: CJ-12420
  • Drug: Esomeprazole 40mg
    -
    Other Name: Nexium
  • Experimental: CJ-12420 50mg
    • Single dose
    • 8 volunteers will be administered CJ-12420 50mg or placebo comparators.(CJ-12420:placebo=6:2)
    Intervention: Drug: CJ-12420
  • Experimental: CJ-12420 100mg
    • Single dose
    • 8 volunteers will be administered CJ-12420 100mg or placebo comparators.(CJ-12420:placebo=6:2)
    Intervention: Drug: CJ-12420
  • Experimental: CJ-12420 200mg
    • Single dose
    • 8 volunteers will be administered CJ-12420 200mg or placebo comparators.(CJ-12420:placebo=6:2)
    Intervention: Drug: CJ-12420
  • Experimental: CJ-12420 400mg
    • Single dose
    • 8 volunteers will be administered CJ-12420 400mg or placebo comparators.(CJ-12420:placebo=6:2)
    Intervention: Drug: 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)
    Intervention: Drug: 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)
    Intervention: Drug: CJ-12420
  • Active Comparator: Esomeprazole 40mg
    8 volunteers will be administered Esomeprazole 40mg
    Intervention: Drug: Esomeprazole 40mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01473173
CJ_APA_101
No
CJ Cheiljedang Corporation
CJ Cheiljedang Corporation
Not Provided
Principal Investigator: Kyun-Seop Bae, MD, Ph.D Asan Medical Center
CJ Cheiljedang Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP