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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DA-6886

Group Type EXPERIMENTAL

DA-6886

Intervention Type DRUG

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)

DA-6886 placebo

Group Type PLACEBO_COMPARATOR

Placebo of DA-6886

Intervention Type DRUG

DA-6886 placebo

Interventions

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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)

Intervention Type DRUG

Placebo of DA-6886

DA-6886 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20 \~ 45 years old
* 27kg/m2 ≥ BMI ≥ 20kg/m2
* Healthy Male
* Informed consent

Exclusion Criteria

* Clinically significant medical history
* smokers
* Clinically significant hypersensitivity of Drugs
* Clinically significant cutaneous disorder
* QTcB \> 450msec
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes