Phase I Clinical Trial of DA-6886 in Healthy Male Subjects | NCT01633723

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

NCT01633723

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Apr 15, 2021Actual

Enrollment

105Actual

Phase

Phase 1

Conditions

Irritable Bowel Syndrome

Interventions

DA-6886
Placebo of DA-6886

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jul 2, 2012

First Submission Date that Met QC Criteria

Jul 3, 2012

First Posted Date

Jul 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-6886	Experimental		Drug: DA-6886
DA-6886 placebo	Placebo Comparator		Drug: Placebo of DA-6886

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-6886	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of safety	Adverse Events Laboratory Results 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

Measure	Description	Time Frame
Pharmacokinetics and Pharmacodynamics	Cmax, Tmax, AUClast, Ae, Cssmax, Cssmin	up to 48 hours after last dosing of DA-6886

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASAN medical center		Seoul	Songpa-gu	138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000594645	N-((1-(3-(1,2,3-triazol-1-yl)propyl)piperidin-4-yl)methyl)-4-amino-5-chloro-2-methoxybenzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided