A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Randomized, Placebo-controlled, Dose-ranging, Single-dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DBPR108 in Healthy Male Subjects|
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 7 days post dose ] [ Designated as safety issue: Yes ]
- Profile of pharmacokinetics [ Time Frame: predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose ] [ Designated as safety issue: No ]Cmax, Area Under Curve, Tmax etc.
- Profile of pharmacodynamics [ Time Frame: predose (0 hr), 1, 2, 4, 8, 16, 24 and 48 hrs post dose ] [ Designated as safety issue: No ]glucose, glucagon, DPP4, GLP-1, insulin and C-peptide
|Study Start Date:||July 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
|Placebo Comparator: matching placebo||
Drug: matching placebo
Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
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 in plasma levels and insulin and C-peptide in serum levels.