- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01154764
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
March 27, 2023 updated by: CrystalGenomics, Inc.
A Randomized, Open, Crossover Clinical Study to Investigate the Effects of Ketoconazole on the Pharmacokinetics of CG100649 in Healthy Male Volunteers
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Asan Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
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
|
I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time
I period: ketoconazole + CG100649 II period: CG 100649
|
Experimental: Group 2
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 |
I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time
I period: ketoconazole + CG100649 II period: CG 100649
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety evaluation-No adverse events
Time Frame: 2 month
|
BP, ECG, urinary electrolytes, Adverse events, vital signs, Fecal occult blood test.
|
2 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyeong-Seok Lim, MD, PhD, Seoul ASAN Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimated)
July 1, 2010
Study Record Updates
Last Update Posted (Actual)
January 3, 2024
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
- CG100649-1-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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