Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04393597
• Other study ID #: DW_DWJ1458102
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWJ1458 (fasted)
Subjects take single dose of DWJ1458 on a fated condition
• DWJ1458 (fed)
Subjects take single dose of DWJ1458 after high-fat diet

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameter of DWJ1458: AUC0-t	Area under the plasma concentration-time curve from time 0 to time t	0 - 144 hours after dosing
Primary	Pharmacokinetic parameter of DWJ1458: Cmax	Maximum plasma drug concentration	0 - 144 hours after dosing
Secondary	Pharmacokinetic parameter of DWJ1458: AUCinf	Area under the plasma concentration-time curve from drug administration to drug elimination	0 - 144 hours after dosing
Secondary	Pharmacokinetic parameter of DWJ1458: Tmax	Time to reach maximum plasma concentration following drug administration	0 - 144 hours after dosing
Secondary	Pharmacokinetic parameter of DWJ1458: t1/2	Elimination half-life	0 - 144 hours after dosing
Secondary	Pharmacokinetic parameter of DWJ1458: Vd/F	Apparent volume of distribution after oral administration	0 - 144 hours after dosing
Secondary	Pharmacokinetic parameter of DWJ1458: Cl/F	Apparent total clearance of drug from plasma after oral administration	0 - 144 hours after dosing