Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

NCT01154764 | Completed Phase 1 Results

• 1 other identifier: CG100649-1-03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

healthy male volunteers

Outcome Measures

Primary Outcomes (2)

• Cmax

  0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose

• AUClast

  0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 240, 384, and 480 hours post-dose

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: CG100649; Drug: Ketoconazole

Group 2

EXPERIMENTAL

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

Drug: CG100649; Drug: Ketoconazole

Interventions

CG100649 DRUG

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

Group 1; Group 2

Ketoconazole DRUG

I period: ketoconazole + CG100649 II period: CG 100649

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24417786 DERIVED

MeSH Terms

Interventions

CG100649; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Hyeong-Seok Lim MD, Ph.D
• Organization: Asan Medical Center

mdihs@amc.seoul.kr

+82 2 3010 4613

Study Officials

• Hyeong-Seok Lim, MD, PhD

  Seoul Asan medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: July 1, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-03

Locations

KR (1)