Phase I Study on Multiple Oral Dosing of CG100649

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01154790
First received: June 16, 2010
Last updated: January 26, 2016
Last verified: June 2010

June 16, 2010
January 26, 2016
June 2010
January 2011   (final data collection date for primary outcome measure)
Safety (normal results for safety tests) [ Time Frame: 27days ] [ Designated as safety issue: Yes ]

Cardiovascular: BP,ECG, Holter monitoring

GI: Fecal occult blood

Kidney: Urine electrolyte test

Adverse events

Physical examination, vital signs

Same as current
Complete list of historical versions of study NCT01154790 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase I Study on Multiple Oral Dosing of CG100649
A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects
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.
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2011
January 2011   (final data collection date for primary outcome measure)

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).
Both
19 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01154790
CG100649-1-04
No
Undecided
Not Provided
CrystalGenomics, Inc.
CrystalGenomics, Inc.
Not Provided
Study Director: Seonggu Ro CrystalGenomics, Inc.
CrystalGenomics, Inc.
June 2010

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