A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a study to assess the pharmacokinetics, safety, and tolerability of sequential single oral doses of MK-8093 10 mg, 40 mg, 200 mg, or placebo to MK-8093 (Part 1) depending on treatment assignment in young healthy male participants. In Part 2 of this study, sequential single oral doses of MK-8093 200 mg, 1000 mg or placebo to MK-8093 depending on treatment assignment will be evaluated. The primary hypothesis of the study is that at least one dose of MK-0893 will produce greater reduction of glucagon-induced glycemia as compared to placebo following the infusion of glucagon, Sandostatine®, and basal insulin.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Glucagon; Glucagon-Like Peptide 1; Insulin; Insulin, Globin Zinc; Molecular Mechanisms of Pharmacological Action; Octreotide

Criteria

Inclusion Criteria:

• Good health

• Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor

• Non-smoker for at least 6 months

• Willing to avoid strenuous physical activity

• Willing to avoid alcohol, caffeine, and grapefruit juice consumption

Exclusion Criteria:

• History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery

• History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food

• History of any cardiovascular/cardiac disease

• History of any hepatic disease and primary biliary cirrhosis

• History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes

• Requires or anticipates use of prescription or nonprescription medications, including herbal remedies

• A user of any illicit drugs or a history of drug or alcohol abuse

• Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation

• History of hypersensitivity to insulin, glucagon, or Sandostatine®.