Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

NCT ID: NCT01154764

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Period 1: CG100649 will be administered alone on Day 1 -After washout period- Period 2: The combination of CG100649 and ketoconazole tabs together on Day 1 followed by ketoconzzole tabs

Group Type: EXPERIMENTAL

CG100649

Intervention Type: DRUG

I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time

Ketoconazole

Intervention Type: DRUG

I period: ketoconazole + CG100649 II period: CG 100649

Group 2

Period 1: The combination of CG100649 and ketoconazole tabs will be administered together on Day 1, followed by ketoconazole tabs for 4 days, for a total of 5 days.

-After washout period- Period 2: CG100649 alone

Group Type: EXPERIMENTAL

CG100649

Intervention Type: DRUG

I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time

Ketoconazole

Intervention Type: DRUG

I period: ketoconazole + CG100649 II period: CG 100649

Interventions

CG100649

I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time

Intervention Type: DRUG

Ketoconazole

I period: ketoconazole + CG100649 II period: CG 100649

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 19-55 years old and weight 50kg above with within 20% of ideal body weight

2. No significant chronic/congenital disease

3. Normal results for lab test

4. Ability of informed consent

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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CrystalGenomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeong-Seok Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul Asan medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24417786 (View on PubMed)

Other Identifiers

CG100649-1-03

Identifier Type: -

Identifier Source: org_study_id