Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649 - Full Text View

Purpose

This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

Condition	Intervention	Phase
Healthy	Drug: CG100649 Drug: CG100649 and ketoconazole	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers

Resource links provided by NLM:

Drug Information available for: Ketoconazole

U.S. FDA Resources

Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:

pharmacokinetic evaluation [ Time Frame: 2 month ] [ Designated as safety issue: No ]
AUClast, Cmax, tmax, AUCinf, t1/2β After administration, the concentration of CG100649 in Plasma

Secondary Outcome Measures:

Safety evaluation-No adverse events [ Time Frame: 2 month ] [ Designated as safety issue: Yes ]
BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test.


Enrollment:	28
Study Start Date:	October 2009
Study Completion Date:	December 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CG100649 study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.	Drug: CG100649 I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days Other Name: CG100649 and ketoconazole Drug: CG100649 and ketoconazole I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days
Experimental: CG100649 and ketoconazole study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.	Drug: CG100649 I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days Other Name: CG100649 and ketoconazole Drug: CG100649 and ketoconazole I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days

Arms

Assigned Interventions

Experimental: CG100649

study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.

Drug: CG100649

I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days

Other Name: CG100649 and ketoconazole

Drug: CG100649 and ketoconazole

I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days

Experimental: CG100649 and ketoconazole

study drug CG100649 (1 mg x 6 capsules) will be administered alone on Day 1, or the combination of CG100649 (1 mg x 6 capsules) and Dongkwang ketoconazole tablets (200 mg x 2 tablets) will be administered together on Day 1, followed by additional Dongkwang ketoconazole tablets (200 mg x 2 tablets) which will be administered once a day for 4 days (Days 2-5), for a total of 5 days.

Drug: CG100649

I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days

Other Name: CG100649 and ketoconazole

Drug: CG100649 and ketoconazole

I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days

Detailed Description:

Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parameters. Concentrations below the lower limit of quantification, samplings which are not applicable, or missing data will be substituted by "<LLOQ", "NA", or "MD" respectively. Pharmacokinetic analyses will be performed on CG100649 only.

Eligibility


Ages Eligible for Study:	19 Years to 55 Years (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 19-55 years old and weight 50kg above with within 20% of ideal body weight
No significant chronic/congenital disease
Normal results for lab test
Ability of informed consent

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

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: NCT01154764

Locations


Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

CrystalGenomics, Inc.

Investigators


Principal Investigator:	Hyeong-Seok Lim, MD, PhD	Seoul Asan medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Youn Choi H, Jin SJ, Jung JA, Kim UJ, Ko YJ, Noh YH, Bae KS, Lim HS. Effects of ketoconazole on the pharmacokinetic properties of CG100649, a novel NSAID: a randomized, open-label crossover study in healthy Korean male volunteers. Clin Ther. 2014 Jan 1;36(1):115-25. doi: 10.1016/j.clinthera.2013.12.004.


Responsible Party:	CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:	NCT01154764 History of Changes
Other Study ID Numbers:	CG100649-1-03
Study First Received:	March 10, 2010
Last Updated:	February 13, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by CrystalGenomics, Inc.:


healthy male volunteers

Additional relevant MeSH terms:


Ketoconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016