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)
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | May 2016 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A Three-part Study Parts I, II and III: Rising Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Subjects (Part I) and Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Subjects With Type 1 Diabetes Mellitus (Part II and Part III).
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.
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
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