NCT02267902

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

October 13, 2014

Last Update Submit

October 15, 2014

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (2)

  • the absolute bioavailability of DA-1229 (F)

    240 hours

  • The mass balance recovery (Ae, %Ae)

    240 hours

Study Arms (2)

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

DA-1229DRUG
Part 1Part 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, Ruddington, United Kingdom

Location

MeSH Terms

Interventions

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 20, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

GB(1)