NCT01650324

A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects

A Double-blind, Randomized, Placebo-controlled, Dose-ranging, Single-dose Study of the Safety, 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 single oral doses of DBPR108 in healthy male subjects.

Detailed description

This study represents the first administration of dipeptidyl peptidase 4 (DPP4) inhibitor DBPR108 to humans to evaluate the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties following single 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 characterize the safety and tolerability of single doses of DBPR108; to characterize the single dose PK of DBPR108 in plasma and urine; to characterize the single dose PD of DBPR108 on glucose, glucagon, dipeptidyl peptidase 4 activity, and total and active forms of glucagon-like peptide-1 (GLP-1) in plasma levels and insulin and C-peptide in serum levels.

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: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-26
• Last updated: 2014-08-28
• Results posted: 2014-08-28

Locations

1 site across 1 country: Taiwan