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Stable isotope tracer

Phase 1

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

Stable isotope tracer target and mechanism

ModalitySmall molecule

Also known as Stable isotope tracer (13-C(4)-BHB)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Stable isotope tracer clinical trials

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 8 trials (matched to "Diabetes")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about Stable isotope tracer

What is the stable isotope tracer (13-C(4)-BHB)?

The stable isotope tracer (13-C(4)-BHB) is a small molecule being developed by Merck & Company, Inc. (MRK) for diabetes. It is a Phase 1 metabolic agent studied as a pharmacodynamic marker of hepatic fatty acid oxidation. It is also known as 13-C(4)-BHB.

Who is developing the stable isotope tracer (13-C(4)-BHB)?

Merck & Company, Inc. (MRK) is developing the stable isotope tracer (13-C(4)-BHB). The company is the sponsor of the Phase 1 trial evaluating the tracer in diabetes.

What phase is the stable isotope tracer (13-C(4)-BHB) in?

The stable isotope tracer (13-C(4)-BHB) is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trial is the stable isotope tracer (13-C(4)-BHB) in?

The stable isotope tracer (13-C(4)-BHB) was studied in a completed Phase 1 trial, NCT00860392, titled 'A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110).' The trial enrolled 24 healthy male volunteers aged 18 years and older and was conducted in diabetes.

Is the stable isotope tracer the same as 13-C(4)-BHB?

Yes, the stable isotope tracer is also known as 13-C(4)-BHB. Both names refer to the same Merck & Company, Inc. (MRK) Phase 1 small molecule being studied in diabetes.