A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)

• Status: Completed
• Trial end date: 2013-09-17
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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