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

NCT03646721 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-02-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2020-05-07
Completion
2020-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646721 on ClinicalTrials.gov