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

History of Changes

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:

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.
No significant congenital/chronic disease. No symptoms in physical examination.
Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
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:

History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
History of known hypersensitivity to drugs including CG100649.
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

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 May 19, 2013

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