Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/1/2014 |
Start Date: | October 2013 |
End Date: | January 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Type 2 Diabetes Mellitus Patients
This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
(PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled
in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic
agents. MK-8666 is planned to be administered orally for up to 2 weeks.
(PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled
in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic
agents. MK-8666 is planned to be administered orally for up to 2 weeks.
Inclusion Criteria:
- If female, must be either postmenopausal or surgically sterile
- A Body Mass Index (BMI) ≥18 kg/m^2 to ≤40 kg/m^2, inclusive.
- A diagnosis of T2DM
- Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents
(thiazolidenediones are excluded)
- Judged to be in good health except for T2DM
- Willing to follow a standard weight maintaining diet throughout the study
- A nonsmoker or has not used nicotine or nicotine-containing products for at least 3
months
Exclusion Criteria:
- A history of clinically significant endocrine (except T2DM), gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases
- A history of myositis or complaints including diffuse myalgias, muscle tenderness, or
weakness.
- A history of cancer (malignancy) excepting adequately treated non-melanomatous skin
carcinoma or carcinoma in situ of the cervix
- Has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of
gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux,
early satiety)
- A history of type 1 diabetes mellitus and/or history of ketoacidosis
- Taking a medication for a co-morbid condition that is not permitted during the study
- A history of significant multiple and/or severe allergies
- Positive for hepatitis B surface antigen, hepatitis C antibodies or human
immunodeficiency virus
- Had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study
participation
- Participated in another investigational trial within 4 weeks prior to study
participation
- Consumes excessive amounts of alcoholic or caffeine-containing beverages
- A regular user of illicit drugs or a history of drug or alcohol abuse within the past
year
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