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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: YH25448 240mg

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; YH25448 240mg single dose in korean	Drug: YH25448 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; Other Names: YH25448
Experimental: Group 2; YH25448 240mg single dose in caucasian	Drug: YH25448 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; Other Names: YH25448

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast of YH25448	Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448	0-192 hrs
Cmax of YH25448	Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448	0-192 hrs

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Collaborators: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; YH25448
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: YH25448-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No