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

Phase 1

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: YH25448 240mg

• Registration Number: NCT03556436
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-14
• Study Start: 2018-07-03
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	YH25448 240mg	YH25448 240mg single dose in korean
Group 2	YH25448 240mg	YH25448 240mg single dose in caucasian

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
AUCinf of YH25448	0-192 hrs	Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448
Tmax of YH25448	0-192 hrs	Time to reach Cmax of YH25448
t1/2 of YH25448	0-192 hrs	Terminal half life (t1/2) of YH25448
CL/F of YH25448	0-192 hrs	The apparent plasma clearance (CL/F) of YH25448
Vd/F of YH25448	0-192 hrs	Apparent Volume of distribution of YH25448

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of