NCT03646721

A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	DA-1241	\[Part1\] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively. \[Part2\] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively. (Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.)
DRUG	Placebo	\[Part1\] Administration once daily for 28 days. \[Part2\] Administration once daily for 56 days.
DRUG	Sitagliptin	\[Part2\] Administration of Sitagliptin 100mg once daily for 56 days.

Timeline

• Start date: 2018-08-29
• Primary completion: 2020-05-07
• Completion: 2020-05-07
• First posted: 2018-08-24
• Last updated: 2021-02-11

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study