A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Unlabeled ertugliflozin for oral use; 14^C-labeled ertugliflozin for IV use; 14^C-labeled ertugliflozin for oral use
Intervention description: 15 mg oral (3 x 5 mg tablets); 100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin); 100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
Intervention MeSH terms: Ertugliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of
      ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and
      intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects between the ages of 18 and 65 years.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110
             lbs.)

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies).

          -  Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).

          -  A positive urine drug screen for drugs of abuse or recreational drugs.

          -  Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
             human immunodeficiency virus (HIV) results.

          -  History of abuse of alcohol or binge drinking and/or any other illicit drug use or
             dependence within 6 months of Screening.

          -  Current smokers and those who have smoked any substance within the last 12 months.

          -  Treatment with an investigational drug within 1 month preceding the first dose of
             study medication.

          -  Have participated in any clinical study with exposure to 14^C in the last 12 months.

          -  Any radiation exposure, including that which is projected to result from the present
             study, excluding background radiation but including diagnostic x-rays and other
             medical exposures. No occupationally exposed worker, as defined in the Ionising
             Radiation Regulation 1999, shall participate in the study.

          -  Use of prescription or nonprescription drugs (including vitamins and dietary
             supplements) within 7 days prior to the first dose of study medication.

          -  Use of herbal supplements within 28 days prior to the first dose of study medication.

          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 56 days prior to dosing.

          -  Participants who have previously participated in a clinical trial for ertugliflozin.

          -  Serious adverse reaction or serious hypersensitivity to any drug or the formulation
             excipients.