Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed)

Detailed Description

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 19 to 55 years
• BMI 18.5≥ and ≤27.0 kg/m²
• Female subjects must be menopause or surgically infertility.
• Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
• Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

• History of hypersensitivity to investigational product
• Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
• The subject who is judged to be unsuitable as a test subject in a screening test.
• The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.	Drug: DWJ1458 (fasted); Subjects take single dose of DWJ1458 on a fated condition; Drug: DWJ1458 (fed); Subjects take single dose of DWJ1458 after high-fat diet
Experimental: Group 2; Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.	Drug: DWJ1458 (fasted); Subjects take single dose of DWJ1458 on a fated condition; Drug: DWJ1458 (fed); Subjects take single dose of DWJ1458 after high-fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter of DWJ1458: AUC0-t	Area under the plasma concentration-time curve from time 0 to time t	0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Cmax	Maximum plasma drug concentration	0 - 144 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter of DWJ1458: AUCinf	Area under the plasma concentration-time curve from drug administration to drug elimination	0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: t1/2	Elimination half-life	0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Vd/F	Apparent volume of distribution after oral administration	0 - 144 hours after dosing
Pharmacokinetic parameter of DWJ1458: Cl/F	Apparent total clearance of drug from plasma after oral administration	0 - 144 hours after dosing

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 28, 2020
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1458102

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