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

October 15, 2014 updated by: Dong-A ST Co., Ltd.

A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Ruddington
      • Nottingham, Ruddington, United Kingdom
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229
Drug: DA-1229
Experimental: Part 2
Single oral therapeutic dose of 5mg [14C]-DA-1229
Drug: DA-1229

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DA1229_BAMB_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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