Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed)

• Registration Number: NCT04393597
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-17
• Study First Posted: 2020-05-19
• Study Start: 2020-05-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-12
• Primary Completion: 2020-07-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	DWJ1458 (fed)	Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.
Group 1	DWJ1458 (fasted)	Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
Group 1	DWJ1458 (fed)	Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
Group 2	DWJ1458 (fasted)	Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of