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Phase I Study on Multiple Oral Dosing of CG100649

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154790
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
Safety (normal results for safety tests) [ Time Frame: 27days ]
Cardiovascular: BP,ECG, Holter monitoring GI: Fecal occult blood Kidney: Urine electrolyte test Adverse events Physical examination, vital signs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study on Multiple Oral Dosing of CG100649
Official Title  ICMJE A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects
Brief Summary The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.
Detailed Description Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CG100649
    6 subjects: study drug 2 subjects: placebo
  • Drug: Placebo
    6 subjects: study drug 2 subjects: placebo
  • Drug: Naproxen
    6 subjects: study drug 2 subjects: placebo
    Other Name: NAXEN
Study Arms  ICMJE
  • Experimental: CG100649
    By the amount of doses, the groups are classified
    Interventions:
    • Drug: CG100649
    • Drug: Placebo
  • Active Comparator: Naproxen
    By the amount of doses, the groups are classified
    Interventions:
    • Drug: Placebo
    • Drug: Naproxen
  • Placebo Comparator: Placebo
    By the amount of doses, the groups are classified
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
120
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2010)
48
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table.
  2. No significant congenital/chronic disease. No symptoms in physical examination.
  3. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
  4. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

  1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
  2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
  3. History of known hypersensitivity to drugs including CG100649.
  4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154790
Other Study ID Numbers  ICMJE CG100649-1-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CrystalGenomics, Inc.
Study Sponsor  ICMJE CrystalGenomics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Seonggu Ro CrystalGenomics, Inc.
PRS Account CrystalGenomics, Inc.
Verification Date June 2010

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