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

Dong-A ST

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DA-1229

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267902

DA1229_BAMB_I

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Part 1

Experimental group

Description:

Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ \[14C\]-DA-1229

Treatment:

Drug: DA-1229

Part 2

Experimental group

Description:

Single oral therapeutic dose of 5mg \[14C\]-DA-1229

Treatment:

Drug: DA-1229