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JNJ-38431055 Dose 1

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: May 22, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-38431055 Dose 1 · 1 trial · 1 indication

Phase 1 1
NCT00871507A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED25 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
NCT0087150725
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Study Endpoints

Primary Endpoints

Incremental glucose AUC after an oral glucose tolerance test (OGTT)
0-4 hours after OGTT

Secondary Endpoints

Incremental glucose AUC after a meal tolerance test (MTT)
0-4 hours after MTT
Measurements of beta-cell function
0-4 hours after OGTT/MTT
Effect on incretin levels
0-4 hours after OGTT
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTAL -
002EXPERIMENTAL -
003PLACEBO_COMPARATOR -
004ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
JNJ-38431055 Dose 1DRUGLiquid suspension/solution of JNJ-38431055 administered as a single dose
Sitagliptin 100 mgDRUGCapsule containing 100 mg of sitagliptin administered as a single dose.
PlaceboDRUGPlacebo suspension/solution and Placebo capsule administered as single doses
JNJ-38431055 Dose 2DRUGLiquid suspension/solution of JNJ-38431055 administered as a single dose
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Eligibility Criteria

Age Range25 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus * Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening * Body Mass Index (BMI) between 22 a...

Countries:United States
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Frequently asked questions about JNJ-38431055 Dose 1

What is JNJ-38431055 Dose 1 used for?

JNJ-38431055 Dose 1 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes JNJ-38431055 Dose 1?

JNJ-38431055 Dose 1 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.

What phase is JNJ-38431055 Dose 1 in?

JNJ-38431055 Dose 1 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use.

What clinical trials is JNJ-38431055 Dose 1 in?

JNJ-38431055 Dose 1 has one completed Phase 1 trial, NCT00871507, which evaluated its safety, tolerability, pharmacokinetics, and pharmacodynamics in 25 volunteers with Type 2 Diabetes Mellitus in the United States.

Is JNJ-38431055 Dose 1 FDA approved?

JNJ-38431055 Dose 1 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial and remains in clinical development.