A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
The purpose of Part I of this study is to evaluate the safety and tolerability of intravenous
 (IV) doses of MK-2640 in healthy participants and to obtain preliminary plasma
 pharmacokinetic profiles of MK-2640. The purpose of Parts II and III of this study is to
 evaluate the safety and tolerability of IV doses of MK-2640 and regular human insulin (RHI),
 and to evaluate the pharmacokinetic and pharmacodynamic profile of MK-2640 and RHI in
 participants with type 1 diabetes mellitus (T1DM). Part II will be initiated only if Part I
 general safety, tolerability and other observed data are supportive of progression to Part
 II. Part III will be initiated only if Parts I and II general safety, tolerability and other
 observed data are supportive of progression to Part III.
Inclusion Criteria (Part I):

 -  healthy male or healthy female of non-child bearing potential

 -  in good health

 -  is a non-smoker and/or has not used nicotine or nicotine-containing products (e.g.,
 nicotine patch) for at least approximately 3 months

 Inclusion Criteria (Parts II and III):

 -  male or female of non-child bearing potential

 -  has T1DM for at least 12 months

 -  on stable doses of insulin

 -  in good health

 -  is a nonsmoker and/or has not used nicotine or nicotine-containing products (e.g.,
 nicotine patch) for at least approximately 3 months

 Exclusion Criteria:

 -  is mentally or legally incapacitated, or has significant emotional problems at the
 time of screening visit or expected during the conduct of the trial or has a history
 of clinically significant psychiatric disorder of the last 5 years

 -  has a history of clinically significant endocrine (except T1DM for Part II subjects),
 gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal,
 respiratory, genitourinary or major neurological (including stroke and chronic
 seizures) abnormalities or diseases

 -  is positive for hepatitis B surface antigen, hepatitis C antibodies or human
 immunodeficiency virus (HIV)

 -  has a history of cancer (malignancy), except adequately treated non-melanomatous skin
 carcinoma or carcinoma in situ of the cervix

 -  has a history of significant multiple and/or severe allergies, or has had an
 anaphylactic reaction or significant intolerability to prescription or
 non-prescription drugs or food, had major surgery, donated or lost 1 unit of blood
 within 4 weeks prior to the screening visit

 -  has participated in another investigational trial within 4 weeks prior to the
 screening visit

 -  is unable to refrain from or anticipates the use of any medication, including
 prescription and non-prescription drugs or herbal remedies beginning approximately 2
 weeks prior to administration of the initial dose of trial drug, throughout the trial,
 until the posttrial visit

 -  consumes greater than 3 glasses of alcoholic beverages daily

 -  consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other
 caffeinated beverages per day.

 -  is currently a regular or recreational user of cannabis, any illicit drugs or has a
 history of drug (including alcohol) abuse within approximately 3 months

 Exclusion Criteria (Parts II and III):

 -  has a history of diabetic ketoacidosis in the last 6 months.

 -  has had one or more severe hypoglycemic episodes associated with hypoglycemic
 seizures, comas or unconsciousness within 2 weeks prior to dosing

 -  has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of
 screening or is anticipated to require treatment with systemic glucocorticoids during
 study participation

 -  has a history of hypersensitivity to pharmacologic insulins or to any of the inactive
 ingredients in regular human insulin, or to any E. coli-derived drug product