NCT01154764

Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	CG100649	I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time
DRUG	Ketoconazole	I period: ketoconazole + CG100649 II period: CG 100649

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-03-01
• Completion: 2010-12-01
• First posted: 2010-07-01
• Last updated: 2024-01-03
• Results posted: 2024-01-03

Locations

1 site across 1 country: South Korea