Clinical 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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®.

Primary outcomes:
measure: Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 1
timeFrame: Up to 76 hours postdose
measure: Post-infusion Incremental Glucose Area Under the Plasma Concentration Versus Time Curve [AUC0-240 min] Study Part 2
timeFrame: Up to 124 hours postdose
Secondary outcomes:
measure: Number of Participants With An Adverse Event (AE)
timeFrame: Up to 12 weeks
measure: Number of Participants Who Discontinued Study Treatment Due To AEs
timeFrame: Up to 21 days of each treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: