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OpenTrials
Completed

NCT Number: NCT01154764

Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CG100649

Drug

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

Ketoconazole

Drug

I period: ketoconazole + CG100649 II period: CG 100649

Primary outcomes

  1. Cmax

    Time frame: 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

  2. AUClast

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CrystalGenomics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2010
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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