drugset / Trial / NCT02012166

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)

NCT02012166

Phase 1 Completed 18 enrolled Merck Sharp & Dohme LLC
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2005-07
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-0893 Small molecule 10 mg Oral
Subject MK-0893 Small molecule 40 mg Oral
Subject MK-0893 Small molecule 200 mg Oral
Subject MK-0893 Small molecule 1000 mg Oral
Background Glucagon Peptide 3 unknown Intravenous
Background Insulin Protein / enzyme biologic 0.1 unknown Intravenous
Background Octreotide Peptide 30 unknown Intravenous