A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: Stable isotope tracer (13-C(4)-BHB)

• Registration Number: NCT00860392
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-02
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2009-07-08
• Study Completion: 2009-07-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-23
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2
• Subject has been a nonsmoker or has not used nicotine for the past 6 months

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Exclusion Criteria

• Subject has a history of diabetes mellitus
• Subject has a history of stroke, chronic seizures, or other neurological disorder
• Subject has a history of cancer, except certain skin cancers
• Subject consumes more than 3 alcoholic beverages per day
• Subject consumes more than 6 servings of caffeinated beverages per day
• Subject has multiple and/or severe allergies to food or drugs
• Subject has allergy or sensitivity to eggs or soy
• Subject regularly uses illicit drugs or has a history of drug or alcohol abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Stable isotope tracer (13-C(4)-BHB)	Biomarker evaluation

Primary Outcome Measures

Name	Time	Method
Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects	5 hours

Secondary Outcome Measures

Name	Time	Method
Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects	5 hours