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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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 Details — Status: Completed

Administrative data

• NCT number: NCT03556436
• Other study ID #: YH25448-101
• Status: Completed
• Phase: Phase 1
• Start date: July 3, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yuhan Corporation	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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