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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Comparator: Oxyntomodulin (OXM); Drug: Comparator: Placebo [ hemaccel-containing saline]; Drug: Oxyntomodulin (OXM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055340

2010_506

159

0000-159

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 6 patient groups

Treatment sequence 1

Experimental group

Description:

OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)

Treatment sequence 2

Experimental group

Description:

OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)

Treatment sequence 3

Experimental group

Description:

Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)

Treatment sequence 4

Experimental group

Description:

OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)

Treatment sequence 5

Experimental group

Description:

Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)

Treatment sequence 6

Experimental group

Description:

OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo

Treatment:

Drug: Comparator: Placebo [ hemaccel-containing saline]

Drug: Oxyntomodulin (OXM)

Drug: Comparator: Oxyntomodulin (OXM)