NCT02163278

A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects

A Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DBPR108 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male subjects.

Detailed description

This study represents the administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties following multiple oral doses in healthy subjects. DPP4 is a validated drug target for the treatment of human type 2 diabetes. Objectives of the study will be to assess the safety and tolerability, PKs and PDs of DBPR108 at steady state after administration of multiple oral doses to healthy male subjects.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	DBPR108	DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
DRUG	matching placebo	Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-06-13
• Last updated: 2016-03-28

Locations

1 site across 1 country: Taiwan