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
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Stable isotope tracer (13-C(4)-BHB)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00860392

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00860392     History of Changes
Other Study ID Numbers: 0000-110, 2009_560
Study First Received: March 11, 2009
Last Updated: March 17, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

ClinicalTrials.gov processed this record on July 20, 2014