Healthy
Conditions
Keywords
healthy male volunteers
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.
Interventions
DRUGCG100649
I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time
DRUGKetoconazole
I period: ketoconazole + CG100649 II period: CG 100649
Sponsors
CrystalGenomics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 and Group 2 Overall Demographic Character | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Group 1 and Group 2 |
|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 2.9 |
| Height | 173.2 centimeters STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 28 Participants |
| Weight | 67.0 kilograms STANDARD_DEVIATION 7.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 28 | 7 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CG100649 6mg + Ketoconazole 400 mg | AUClast | 2685.8 h∙ng/mL | Standard Deviation 551.1 |
| CG100649 6mg Single Dosing | AUClast | 2074 h∙ng/mL | Standard Deviation 442.9 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CG100649 6mg + Ketoconazole 400 mg | Cmax | 11.0 ng/mL | Standard Deviation 2.4 |
| CG100649 6mg Single Dosing | Cmax | 107 ng/mL | Standard Deviation 2.4 |