A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: MK-8521 35μg; MK-8521 100μg; MK-8521 125μg; MK-8521 150μg; MK-8521 175μg; MK-8521 200μg; MK-8521 300μg; MK-8521 50/72μg; MK-8521 72/125μg; MK-8521 100/150μg; MK-8521 125/150μg; Placebo
Intervention description: Single dose 35μg subcutaneous (SC) injection in a treatment period (Part 3, Panel H); Single dose 100μg SC injection in a treatment period (Part 1, Panel A) and (Part 2, Panel D); Single dose 125μg SC injection in a treatment period (Part 2, Panel E) and (Part 3, Panel H); Single dose 150μg SC injection in a treatment period (Part 1, Panel B); Single dose 175μg SC injection in a treatment period (Part 1, Panel B); Single dose MK-8521 200μg SC injection in a treatment period (Part 1, Panel B); Single dose 300μg SC injection in a treatment period (Part 1, Panel A); MK-8521 50μg SC injection Days 1-5 and 72μg Days 6-10 (Part 2, Panel C); MK-8521 72μg SC injection Days 1-7 and 125μg Days 8-14 (Part 2, Panel F); MK-8521 100μg SC injection Days 1-5 and 150μg Days 6-10 SC in a treatment period (Part 2, Panel D); MK-8521 SC 125μg SC injection Days 1-5 and 150μg Days 6-10 (Part 2, Panel E); Placebo to MK-8521 SC injection in a treatment period (Parts 1, 2, and 3)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parts 1 and 2 were parallel in design and Part 3 was crossover in design.
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      MK-8521.

      Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is
      sufficiently safe and well- tolerated in healthy participants, based on assessment of
      clinical and laboratory adverse experiences, to permit continued clinical investigation.

      Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and
      well-tolerated in healthy lean and obese participants, based on assessment of clinical and
      laboratory adverse experiences, to permit continued clinical investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males of either 18 to 45 or 45 to 70 years of age depending on the component of the
             study

          -  Body Mass Index between either 18-25 or 30-40 kg/m^2 depending on the component of the
             study

          -  Is in good health

          -  Is a non-smoker and/or has not used nicotine for at least 3 months

        Exclusion Criteria:

          -  Is mentally or legally incapacitated, has significant emotional problems or has a
             history of psychiatric disorders in the past 5 years

          -  Has a history of the following abnormalities or diseases: endocrine, gastrointestinal,
             cardiovascular, hematological, hepatic, immunological, renal, respiratory,
             genitourinary, or major neurological.

          -  History of cancer

          -  History of significant multiple or severe allergies or has had an anaphylactic
             reaction or significant intolerability to drugs or food

          -  Positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV)

          -  Had major surgery, donated or lost 1 unit (500 mL) of blood or participated in another
             study within prior 4 weeks

          -  Has irritable bowel disease or recurrent nausea, vomiting, diarrhea or abdominal pain

          -  History of acute or chronic pancreatitis

          -  Uses 2 weeks prior to trial, or anticipates using during trial, medications, drugs or
             herbal remedies such as St. John's Wort

          -  Consumes greater than 3 glasses of alcohol per day

          -  Consumes greater than 6 servings of caffeinated beverages per day

          -  Regularly uses illicit drugs or has a history of drug (including alcohol) abuse within
             prior 3 months

          -  Has known hypersensitivity to glucagon or any glucagon like peptide 1 (GLP-1) receptor
             agonist

          -  Is unwilling/unable to consume standardized meals and/or is on a carbohydrate
             restricted diet

          -  Has history of hypersensitivity to pharmacologic insulins