Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CG100649; Drug: Ketoconazole

• Registration Number: NCT01154764
• Lead Sponsor: CrystalGenomics, Inc.

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Study Completion: 2010-12
• Results First Submitted: 2016-08-17
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Results First Posted: 2024-01-03
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CG100649	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 2	CG100649	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 1	Ketoconazole	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 2	Ketoconazole	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

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of