NCT05207176

Study to Evaluate the Safety and PK Properties of DWP16001 in Healthy Subjects With Various Ethnicities

An Open-label, Single-center, Parallel, Single and Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP16001 in Healthy Koreans, Caucasians, and Hispanics

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

An open label, single center, parallel, single and multiple oral dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of DWP16001 in healthy Koreans, Caucasians, and Hispanics

Detailed description

This study is conducted with single center, parallel design, single and repeated administration and repeated administration. 1. Screening (28d\~ 2d) For volunteers, screening tests such as questionnaire, physical examination and clinical examination are conducted within 4 weeks (-28d\~-2d) from the date of administration of the clinical investigational drug (1d), and subjects judged to be suitable for this clinical trial are selected. 2. Dosing and Pharmacokinetics/Pharmacodynamic Evaluators (1d to 12d) The subjects who are judged to be suitable for this clinical trial are admitted to the clinical trial center of Seoul National University Hospital in the afternoon of 1 day (-1d) before administration. In order to maintain an empty stomach for at least 10 hours before administration of clinical trial drugs, fast except for drinking water after 10 p.m. 3. PSV (17d \~ 21d) The post-study visit is conducted on 17d to 21d, about one week after the last dosing date.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP16001	Subjects should fast except for drinking water after 10 p.m. in order to maintain a fasting state for at least 10 hours before administration. On dosing days (5d to 10d), except for 1d and 11d, breakfast can be consumed from about 1 hour after administration of the clinical trial drug. Subjects should swallow the investigational drug whole with 150 mL of water, and should not chew the drug before swallowing. Subjects should fast for 4 hours after dosing, and can drink water freely from 2 hours after dosing.

Timeline

• Start date: 2022-02-14
• Primary completion: 2022-04-08
• Completion: 2022-08-31
• First posted: 2022-01-26
• Last updated: 2022-01-26