Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 26 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02269735
Start Date
November 26 2014
End Date
July 29 2016
Last Update
January 15 2019
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