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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00860392
First received: March 11, 2009
Last updated: March 17, 2014
Last verified: March 2014

March 11, 2009
March 17, 2014
March 2009
July 2009   (final data collection date for primary outcome measure)
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 [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00860392 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
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.
Experimental: 1
Biomarker evaluation
Intervention: Drug: Stable isotope tracer (13-C(4)-BHB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00860392
0000-110, 2009_560
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP