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)

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: MK-0893 10 mg (Drug); MK-0893 40 mg (Drug); MK-0893 200 mg (Drug); MK-0893 1000 mg (Drug); Placebo (Drug); Sandostatine® (Biological); Insulin (Biological); Glucagon (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, 3-Period, 4 Treatment Incomplete Crossover Study to Assess the Effects of Single Oral Doses of L-001241689 on Glucagon-Induced Glycemic Excursion in Healthy Male Subjects Following Intravenous Administration of Glucagon, Sandostatine® and Insulin

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1

Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2

Secondary outcome:

Number of Participants With An Adverse Event (AE)

Number of Participants Who Discontinued Study Treatment Due To AEs

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

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®.

Starting date: July 2005
Last updated: August 18, 2015