Skip to main content
OpenTrials
Completed

NCT Number: NCT03556436

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: YH25448

Primary outcomes

  1. AUClast of YH25448

    Time frame: 0-192 hrs

    Area under the plasma concentration-time curve from zero to the time of the last quantitative concentration (AUC) of YH25448

  2. Cmax of YH25448

    Time frame: 0-192 hrs

    Area under the plasma concentration-time curve from zero to the time of Maximum plasma concentration (Cmax) of YH25448

Secondary outcomes

  1. AUCinf of YH25448

    Time frame: 0-192 hrs

    Area under the plasma concentration time curve from zero to infinity (AUC) of YH25448

  2. Tmax of YH25448

    Time frame: 0-192 hrs

    Time to reach Cmax of YH25448

  3. t1/2 of YH25448

    Time frame: 0-192 hrs

    Terminal half life (t1/2) of YH25448

  4. CL/F of YH25448

    Time frame: 0-192 hrs

    The apparent plasma clearance (CL/F) of YH25448

  5. Vd/F of YH25448

    Time frame: 0-192 hrs

    Apparent Volume of distribution of YH25448

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Collaborators

  • Seoul National University Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.