NCT01633723

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

July 2, 2012

Last Update Submit

April 13, 2021

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Assessment of safety

    1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG

    up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)

Secondary Outcomes (1)

  • Pharmacokinetics and Pharmacodynamics

    up to 48 hours after last dosing of DA-6886

Study Arms (2)

DA-6886

EXPERIMENTAL
Drug: DA-6886

DA-6886 placebo

PLACEBO COMPARATOR
Drug: Placebo of DA-6886

Interventions

DA-6886DRUG

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 of DA-6886DRUG

DA-6886 placebo

DA-6886 placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASAN medical center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

N-((1-(3-(1,2,3-triazol-1-yl)propyl)piperidin-4-yl)methyl)-4-amino-5-chloro-2-methoxybenzamide

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 4, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

KR(1)