Microtracer Study to Establish Absolute Bioavailability a... | NCT02267902

Studies
Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229

NCT02267902

Sponsor

Dong-A ST Co., Ltd.

Status

Unknown status

Last Update Posted

Oct 20, 2014Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

DA-1229

Countries

United Kingdom

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

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Oct 13, 2014

First Submission Date that Met QC Criteria

Oct 15, 2014

First Posted Date

Oct 20, 2014Estimated

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

Oct 15, 2014

Last Update Posted Date

Oct 20, 2014Estimated

Description Module

Brief Summary

The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1	Experimental	Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229	Drug: DA-1229
Part 2	Experimental	Single oral therapeutic dose of 5mg [14C]-DA-1229	Drug: DA-1229

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-1229	Drug		Part 1 Part 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the absolute bioavailability of DA-1229 (F)		240 hours
The mass balance recovery (Ae, %Ae)		240 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males
Age 18 to 55
BMI 18.0 to 30.0 kg/㎡

Exclusion Criteria:

History of any drug or alcohol abuse in the past 2years
Regular alcohol consumption nin males >21 units per week
Current smokers and those who have smoked within the last 12months
Radiation Exposure
Positive drugs of abuse test result
Positive HBsAg, HCV Ab, HIV results
Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
Clinically significant allergy
Donation of loss of blood within the previous 3 months
Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 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
Quotient Clinical		Nottingham	Ruddington		United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C557982	4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided