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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02267902
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DA-1229	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: 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
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Jan 1, 2015
• Anticipated Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the absolute bioavailability of DA-1229 (F) [240 hours]

2. The mass balance recovery (Ae, %Ae) [240 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical	Nottingham	Ruddington	United Kingdom

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02267902
• Other Study ID Numbers: DA1229_BAMB_I
• First Posted: Oct 20, 2014
• Last Update Posted: Oct 20, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Dong-A ST Co., Ltd.: Volunteers

Study Results

No Results Posted as of Oct 20, 2014