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A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163278
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: DBPR108 Drug: matching placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: DBPR108 Drug: DBPR108
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 -1. 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 -1.
  • 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 -1.
  • Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or at admission on Day -1.
  • 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.
  • Has donated blood or participated in another clinical study within 8 weeks before Day -1.
  • Excessive intake of caffeine-containing drinks or food (i.e., coffee, tea, chocolate, PAOLYTA B Liq, WHISBIH Liq, or cola [more than 6 units of caffeine per day]). One caffeine unit is contained in the following items: 1 (177.4 mL) cup of coffee, 2 (354.9 mL) cans of cola, 1 (354.9 mL) cup of tea, ½ (118.3 mL) cup of energy drink (e.g., PAOLYTA B Liq or WHISBIH Liq), or 3 oz of chocolate.
  • Use of drugs with cytochrome P450 enzyme-inducing or
  • inhibiting properties within 4 weeks prior to the first administration of investigational product.
  • Has used prescription or nonprescription medication (except for occasional use of paracetamol or nasal spray) or herbal remedies or vitamins or minerals within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to dosing until end of study.
  • Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of investigational product.
  • Male subjects who are unwilling to use barrier contraception in addition to having their partner use another method of contraception, for the duration of the study and for 3 months after dosing.
  • Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
  • Has received a blood transfusion and/or has HCV infection.
  • Positive result on screening for drugs of abuse, alcohol, or cotinine (nicotine) at screening or on Day -1.
  • Involved in the planning or conduct of the study.

Information from the National Library of Medicine

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


Locations
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Taiwan
Taipei Medical University - Taipei Medical University Hospital
Taipei, Taiwan, 11031
Sponsors and Collaborators
National Health Research Institutes, Taiwan
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Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT02163278    
Other Study ID Numbers: DBPR108-102
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: April 2015
Keywords provided by National Health Research Institutes, Taiwan:
DBPR108
DPP4
Diabetes
Glucagon-like peptide-1 (GLP-1)
Incretins
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases