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
  Purpose
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 Intervention Phase
Healthy
Drug: CG100649
Drug: Placebo
Drug: Naproxen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • 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



Enrollment: 120
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154790

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Study Director: Seonggu Ro CrystalGenomics, Inc.
  More Information

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01154790     History of Changes
Other Study ID Numbers: CG100649-1-04 
Study First Received: June 16, 2010
Last Updated: January 26, 2016
Health Authority: Korea: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by CrystalGenomics, Inc.:
healthy volunteers

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 26, 2016