A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01650324
First received: July 19, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: DBPR108
Drug: matching placebo
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 71
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 in plasma levels and insulin and C-peptide in serum levels.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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 study drug intact;
  • Aged between 20 and 45 years (inclusive) at the screening visit; and
  • 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 kg/m2 or greater than 30 kg/m2 at the screening visit;
  • 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 for the residential period;
  • Is not normoglycemic defined as fasting glucose at less than 70 mg/dL (3.9 mmol/L) and greater than 100 mg/dL (5.5 mmol/L);
  • Has a platelet count less than 150,000/µL;
  • Uses any antihyperglycemic agents at screening or at admission for the residential period;
  • 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 for the residential period;
  • Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or at admission for the residential period;
  • 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 preceding the day of admission;
  • Excessive intake of caffeine-containing drinks or food (ie, coffee, tea, chocolate, PAOLYTA B Liq, WHISBIH Liq, or cola [more than 6 units of caffeine per day]);
  • Use of drugs with enzyme-inducing properties such as St. John's Wort 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 admission; or
  • Involved in the planning or conduct of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650324

Locations
Taiwan
Taipei Medical University - Wanfang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
National Health Research Institutes, Taiwan
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01650324     History of Changes
Other Study ID Numbers: DBPR108-101
Study First Received: July 19, 2012
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration

Keywords provided by National Health Research Institutes, Taiwan:
DBPR108
DPP4
Diabetes
GLP-1
Incretins

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014