NCT02622685

A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects

A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.

Detailed description

This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWP10292	Drug: DWP10292 tablets, oral administration, multiple administration
DRUG	DWP10292 Placebo	Placebo tablets, oral administration, multiple administrations
DRUG	Ursodeoxycholic acid (UDCA)	Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration
DRUG	UDCA Placebo	Placebo tablets, oral administration, multiple administrations

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-12-04
• Last updated: 2016-06-02