NCT03061981

A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects

A Phase I, First In Human, Double Blind, Placebo Controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Interaction Effect With Metformin Following A Single Oral Dose Of DA-1241 In Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double blind, placebo controlled, single ascending dose study to assess the safety, tolerability, PK, PD and IE with metformin following a single oral dose of DA-1241 in healthy male subjects.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Placebo	After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period.
DRUG	Metformin	Subjects in the IE cohort will receive 500 mg metformin (IR formulation) at 12 hours on Day 1 and a single oral dose of the IMP with 500 mg metformin (IR formulation) after an overnight fast on Day 1, in Treatment Period 2.
DRUG	DA-1241	After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period .

Timeline

• Start date: 2017-03-29
• Primary completion: 2017-10-11
• Completion: 2017-10-11
• First posted: 2017-02-23
• Last updated: 2017-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study