Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

NCT01154764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-01-03

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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

Interventions

DRUG

CG100649

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

DRUG

Ketoconazole

I period: ketoconazole + CG100649 II period: CG 100649

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Hyeong-Seok Lim, MD, PhD · Seoul Asan medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154764 on ClinicalTrials.gov