Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229
- Registration Number
- NCT02267902
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 12
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 DA-1229 Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ \[14C\]-DA-1229 Part 2 DA-1229 Single oral therapeutic dose of 5mg \[14C\]-DA-1229
- Primary Outcome Measures
Name Time Method the absolute bioavailability of DA-1229 (F) 240 hours The mass balance recovery (Ae, %Ae) 240 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Clinical
🇬🇧Nottingham, Ruddington, United Kingdom