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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02267902

Enrollment

Registered

2014-10-20

Start date

2014-09-30

Completion date

2015-01-31

Last updated

2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Volunteers

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.

Interventions

DRUGDA-1229

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026