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

National Health Research Institutes, Taiwan1 site in 1 country32 target enrollmentJune 2014

ConditionsDiabetes Mellitus, Type 2

InterventionsDBPR108 matching placebo

Overview

Phase: Phase 1
Intervention: DBPR108
Conditions: Diabetes Mellitus, Type 2
Sponsor: National Health Research Institutes, Taiwan
Enrollment: 32
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

January 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

National Health Research Institutes, Taiwan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male with suitable veins for cannulation or repeated venipuncture, and must be able to swallow the investigational product intact.
•Aged between 20 and 45 years (inclusive) at the screening visit.
•Able to provide written informed consent and willing to comply with the study protocol procedures and restrictions.

Exclusion Criteria

•Has a body weight less than 50 kg and/or body mass index (BMI) less than 18.5 kg/m2 or greater than or equal to 24 kg/m2 at the screening visit. Body mass index is determined as total body weight/height2 (kg/m2).
•Has a creatinine clearance (Ccr) less than 80 mL/min at screening.
•Is not in good general health as judged by the Investigator based on routine medical history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at the screening visit or at admission on Day -
•Normal ECG includes (1) sinus rhythm, (2) pulse rate between 45 and 90 bpm, (3) Corrected QT (QTc) interval equal to or less than 450 ms (corrected cf Bazett 1920), (4) QRS interval less than 110 ms, (5) PR interval less than 200 ms, and (6) morphology consistent with healthy cardiac conduction and function.
•Is not normoglycemic defined as fasting glucose at less than 70 mg/dL (3.9 mmol/L) and greater than 99 mg/dL (5.5 mmol/L), based on the laboratory tests at screening or at admission on Day -1, or has known diabetes or impaired glucose tolerance (Re-testing of fasting glucose on the same sample collected from the subject with initial fasting glucose value of 100-105 mg/dL on Day -1 is acceptable. However, if the re-testing fasting glucose value is still greater than 99 mg/dL, the subject shall be excluded and considered as screen-failure).
•Has a platelet count less than 150,000/μL.
•Uses any antihyperglycemic agents at screening or at admission on Day -
•Has a history or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs at the screening visit or at admission on Day -
•Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or at admission on Day -
•Is a smoker and/or has used nicotine-containing products within the last 6 months prior to the screening for the current study and/or has a history of alcohol abuse.

Arms & Interventions

DBPR108

Intervention: DBPR108

matching placebo

Intervention: matching placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

Pharmacodynamic parameters(34 time points during 10 days (including measurements before dosing))
Pharmacokinetic parameters(33 time points during 12 days (including measurements before dosing))