A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: DBPR108; matching placebo
Intervention description: DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.; Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DBPR108; DPP4; Diabetes; GLP-1; Incretins

Summary:

      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.
    

Eligibility 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.