Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04393597

Collaborator

(none)

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWJ1458 (fasted) Drug: DWJ1458 (fed)	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 28, 2020

Anticipated Primary Completion Date :

Jul 31, 2020

Anticipated Study Completion Date :

Nov 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
Pharmacokinetic parameter of DWJ1458: Cl/F [0 - 144 hours after dosing]
Apparent total clearance of drug from plasma after oral administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT04393597

Other Study ID Numbers:

DW_DWJ1458102

First Posted:

May 19, 2020

Last Update Posted:

Jun 12, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 12, 2020