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

NCT03556436 | Completed Phase 1

• 1 other identifier: YH25448-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

YH25448; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUCinf of YH25448

  0-192 hrs

• Tmax of YH25448

  0-192 hrs

• t1/2 of YH25448

  0-192 hrs

• CL/F of YH25448

  0-192 hrs

• Vd/F of YH25448

  0-192 hrs

Study Arms (2)

Group 1

EXPERIMENTAL

YH25448 240mg single dose in korean

Drug: YH25448 240mg

Group 2

EXPERIMENTAL

YH25448 240mg single dose in caucasian

Drug: YH25448 240mg

Interventions

YH25448 240mg DRUG

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

Also known as: YH25448

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed of the investigational nature of this study and voluntarily agree to participate in this study.
• Subjects with BMI range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg
• Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
• Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent

You may not qualify if:

• Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness
• Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
• A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula
• 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

Sponsors & Collaborators

• Yuhan Corporation: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: July 3, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)