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

A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Stable isotope tracer (13-C(4)-BHB)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Biomarker evaluation	Drug: Stable isotope tracer (13-C(4)-BHB); A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2009
• Primary Completion (Actual): July 8, 2009
• Study Completion (Actual): July 8, 2009

Study Registration Dates

• First Submitted: March 11, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (Estimate): March 12, 2009

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0000-110; 2009_560