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

NCT00860392 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-11-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-02
Primary Completion
2009-07-08
Completion
2009-07-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860392 on ClinicalTrials.gov