A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

Study Overview
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Brief Summary
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This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.

Official Title
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A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: Oxyntomodulin (OXM)
* Drug: Comparator: Oxyntomodulin (OXM)
* Drug: Comparator: Placebo [ hemaccel-containing saline]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study Exclusion Criteria: Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain Subject has a history of hypertension requiring treatment Subject has a history of cancer Subject has history of diabetes, or family history of diabetes mellitus Subject has a history of hypersensitivity to OXM or hemaccel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence 1<br>OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|
| Experimental: Treatment sequence 2<br>OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|
| Experimental: Treatment sequence 3<br>Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|
| Experimental: Treatment sequence 4<br>OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|
| Experimental: Treatment sequence 5<br>Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|
| Experimental: Treatment sequence 6<br>OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo | Drug: Oxyntomodulin (OXM)<br>* Single infusion of OXM 3.0 pmol/kg/min by IV<br>Drug: Comparator: Oxyntomodulin (OXM)<br>* Single infusion of OXM 0.6 pmol/kg/min by IV<br>Drug: Comparator: Placebo [ hemaccel-containing saline]<br>* Single Placebo infusion of hemaccel-containing saline by IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambient plasma glucose concentration during the GGI |  | Last 160 minutes of OXM/placebo infusion | 
| plasma βOHB + AcAc concentrations |  | First 300 minutes of OXM/placebo infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketogenesis, Glucose-Dependent Insulin Secretion, Graded Glucose Infusion, Oxyntomodulin