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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02267902
• Other study ID #: DA1229_BAMB_I
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: October 13, 2014
• Last updated: October 15, 2014
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DA-1229

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the absolute bioavailability of DA-1229 (F)		240 hours	No
Primary	The mass balance recovery (Ae, %Ae)		240 hours	No