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Stable isotope tracer

Phase 1

Diabetes | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Nov 27, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Stable isotope tracer · 1 trial · 1 indication

Phase 1 1
NCT00860392A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)Diabetes
COMPLETED24 Analytics
PHASE1COMPLETED
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBiomarker evaluation

Interventions

NameTypeDescription
Stable isotope tracer (13-C(4)-BHB)DRUGA 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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes

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 neurologic...

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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about Stable isotope tracer

What is Stable isotope tracer used for in Diabetes?

Stable isotope tracer is an investigational small molecule being studied for use in Diabetes. It is a metabolic therapeutic being developed by Merck & Company, Inc. (MRK). The compound is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials and is not yet approved for any use.

Who makes Stable isotope tracer?

Stable isotope tracer is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational small molecule for the treatment of Diabetes. Merck is responsible for the development and potential future commercialization of this metabolic therapeutic.

What phase is Stable isotope tracer in?

Stable isotope tracer is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the compound is still in the early stages of clinical testing for Diabetes.

What clinical trials is Stable isotope tracer in?

Stable isotope tracer has one completed Phase 1 clinical trial, identified as NCT00860392. The study, titled 'A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)', enrolled 24 male participants aged 18 years and older, including healthy volunteers, and focused on Diabetes.

Is Stable isotope tracer FDA approved?

Stable isotope tracer is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Diabetes. The Phase 1 trial has been completed, but the compound has not yet received regulatory approval and remains in the early stages of clinical testing.