A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT02163278|
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : March 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: DBPR108 Drug: matching placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DBPR108 in Healthy Male Subjects|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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.
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Each subject will be followed for the duration of 6 hospital stays, an expected average of 5 weeks ]
- Pharmacokinetic parameters [ Time Frame: 33 time points during 12 days (including measurements before dosing) ]PK parameters are including: Cmax, Cmin, Cavg, Cmin,i , Tmax, Tlast, t1/2, AUCτ, AUC0-t, AUC0-inf, % Fluctuation, Apparent body clearance following extravascular dosing (CL/F), Vz/F, Aet1-t2, Ae0-t, fe0-t, Renal clearance (CLR), Accumulation index (AI) and Accumulation ration (AR)
- Pharmacodynamic parameters [ Time Frame: 34 time points during 10 days (including measurements before dosing) ]PD parameters are including: Emax, Emin, Time to maximum effect (TEmax), TEmin, Area under the response versus time curve during a dosing interval ( AUECτ) and Area under the response versus time curve from time zero to the time of last quantifiable response (AUEC0-t)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163278
|Taipei Medical University - Taipei Medical University Hospital|
|Taipei, Taiwan, 11031|