NCT01633723

Phase I Clinical Trial of DA-6886 in Healthy Male Subjects

A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

DA-6886\_IBS\_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	DA-6886	single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation) multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)
DRUG	Placebo of DA-6886	DA-6886 placebo

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-07-04
• Last updated: 2021-04-15

Locations

1 site across 1 country: South Korea