Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

NCT04393597 | Withdrawn Phase 1

• 1 other identifier: DW_DWJ1458102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Pharmacokinetic parameter of DWJ1458: AUCinf

  0 - 144 hours after dosing

• Pharmacokinetic parameter of DWJ1458: Tmax

  0 - 144 hours after dosing

• Pharmacokinetic parameter of DWJ1458: t1/2

  0 - 144 hours after dosing

• Pharmacokinetic parameter of DWJ1458: Vd/F

  0 - 144 hours after dosing

• Pharmacokinetic parameter of DWJ1458: Cl/F

  0 - 144 hours after dosing

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.

Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed)

Group 2

EXPERIMENTAL

Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.

Drug: DWJ1458 (fasted); Drug: DWJ1458 (fed)

Interventions

DWJ1458 (fasted) DRUG

Subjects take single dose of DWJ1458 on a fated condition

Group 1; Group 2

DWJ1458 (fed) DRUG

Subjects take single dose of DWJ1458 after high-fat diet

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: May 28, 2020
• Primary Completion: July 31, 2020
• Study Completion: November 30, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)