Clinical trial · Interventional
Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448
An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| YH25448 240mg | Drug | Lazertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- YH25448 240mg single dose in korean
- interventionNames
- Drug: YH25448 240mg
- type
- EXPERIMENTAL
- label
- Group 2
- description
- YH25448 240mg single dose in caucasian
- interventionNames
- Drug: YH25448 240mg
Primary outcomes (2)
- measure
- AUClast of YH25448
- timeFrame
- 0-192 hrs
- description
- Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available