NCT04982705 - IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 7, 2021

Primary Completion Date

November 9, 2022

Study Completion Date

December 30, 2022

Conditions

Type 2 Diabetes

Interventions

DRUG

[Part 1.1] IDG-16177

\[Part 1.1\] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively.

DRUG

[Part 1.1] Placebo of IDG-16177

\[Part 1.1\] subjects will receive a single oral dose of IMP.

DRUG

[Part 2] Sitagliptin

Administration of Sitagliptin 100mg once daily for 4 weeks.

DRUG

[Part1.2] IDG-16177

\[Part 1.2\] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively.

DRUG

[Part 2] IDG-16177

\[Part 2\] Administration once daily for 4 weeks.

DRUG

[Part 1.2] Placebo of IDG-16177

\[Part 1.2\] Administration once daily for 14 days.

DRUG

[Part 2] Placebo of IDG-16177

\[Part 2\] Administration once daily for 4 weeks.

Trial Locations (1)

14050

RECRUITING

Parexel International GmbH Early Phase Clinical Unit Klinikum Westend, Berlin