Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Collaborator: Seoul National University Hospital

Criteria

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