Clinical Study for the Evaluation of the Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability on Multiple Oral Dosing of CG100649

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by CrystalGenomics, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01154790
First received: June 16, 2010
Last updated: June 30, 2010
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

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



Estimated Enrollment: 48
Study Start Date: June 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort 1-3
By the amount of doses, the groups are classified
Drug: placebo

6 subjects: study drug

2 subjects: placebo

Experimental: Drug
For each cohort, 6subjects have study drugs and 2 subjects have placebos
Drug: CG100649

6 subjects: study drug

2 subjects: placebo


  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
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

Contacts
Contact: Kyun-Seop Bae, Dr. Ph.D. 82-2-3010-4613 ksbae@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyung-seop Bae, MD, PhD    82-2-3010-4613    ksbae@amc.seoul.kr   
Sponsors and Collaborators
CrystalGenomics, Inc.
  More Information

No publications provided

Responsible Party: Seonggu Ro, PhD /Vice president, CrystalGenomics
ClinicalTrials.gov Identifier: NCT01154790     History of Changes
Other Study ID Numbers: CG100649-1-04
Study First Received: June 16, 2010
Last Updated: June 30, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:
healthy volunteers

ClinicalTrials.gov processed this record on July 26, 2014