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Phase I Study on Multiple Oral Dosing of CG100649

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CG100649 Drug: Placebo Drug: Naproxen Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects
Study Start Date : June 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Naproxen

Arms and Interventions
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Arm Intervention/treatment
Experimental: CG100649
By the amount of doses, the groups are classified
 Drug: CG100649
6 subjects: study drug 2 subjects: placebo

Drug: Placebo
6 subjects: study drug 2 subjects: placebo
Active Comparator: Naproxen
By the amount of doses, the groups are classified
 Drug: Placebo
6 subjects: study drug 2 subjects: placebo

Drug: Naproxen
6 subjects: study drug 2 subjects: placebo
Other Name: NAXEN
Placebo Comparator: Placebo
By the amount of doses, the groups are classified
 Drug: Placebo
6 subjects: study drug 2 subjects: placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154790


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
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Study Director: Seonggu Ro CrystalGenomics, Inc.
More Information
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Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01154790    
Other Study ID Numbers: CG100649-1-04
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: June 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by CrystalGenomics, Inc.:
healthy volunteers
Additional relevant MeSH terms:
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Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action