Non-Small Cell Lung Cancer
Conditions
Keywords
YH25448, Non-Small Cell Lung Cancer
Brief summary
Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.
Detailed description
This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.
Interventions
DRUGYH25448 240mg
period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast
Sponsors
Seoul National University Hospital
Yuhan Corporation
Study design
Allocation
NON_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. Informed of the investigational nature of this study and voluntarily agree to participate in this study. 2. Subjects with BMI range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg 3. Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis 4. Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent
Exclusion criteria
1. Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness 2. Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg) 3. A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula 4. Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast of YH25448 | 0-192 hrs | Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448 |
| Cmax of YH25448 | 0-192 hrs | Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| t1/2 of YH25448 | 0-192 hrs | Terminal half life (t1/2) of YH25448 |
| AUCinf of YH25448 | 0-192 hrs | Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448 |
| Vd/F of YH25448 | 0-192 hrs | Apparent Volume of distribution of YH25448 |
| CL/F of YH25448 | 0-192 hrs | The apparent plasma clearance (CL/F) of YH25448 |
| Tmax of YH25448 | 0-192 hrs | Time to reach Cmax of YH25448 |
Countries
South Korea
Outcome results
None listed