Conditions: Diabetes Mellitus, Type 2
Keywords: DBPR108 DPP4 Diabetes GLP-1 Incretins
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: DBPR108 intervention 2: matching placebo
Intervention descriptions: intervention 1: DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg. intervention 2: Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.

Protocol document: