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JNJ-38431055

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Johnson & Johnson|Last Updated: Sep 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-38431055 · 2 trials · 1 indication

Phase 1 2
NCT01054118A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and SitagliptinDiabetes Mellitus, Type 2
COMPLETED18 Analytics
NCT00910923A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male VolunteersDiabetes Mellitus, Type 2
COMPLETED37 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

GLP-1 levels after a standard meal
0-4 hours after the standard meal
To assess the safety and tolerability of JNJ-38431055

Secondary Endpoints

To evaluate the pharmacokinetics of JNJ-38431055 administered alone and in combination with sitagliptin.
24 hours after dosing
Assess the effect of JNJ-38431055 on appetite and satiety using a visual analogue scale (VAS)
Within 24 hours of dosing
Assess the safety and tolerability of JNJ-38431055 administered alone and in combination with sitagliptin as measured by occurrence of adverse events, ECGs, vital signs, and safety laboratory measurements.
From screening visit through follow-up visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose
002ACTIVE_COMPARATORSitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose
003EXPERIMENTALJNJ-38431055 + Sitagliptin 100 mg Liquid suspension of JNJ-38431055 administered as a single dose and capsule containing 100 mg of sitagliptin administered as a single dose
004PLACEBO_COMPARATORPlacebo Placebo suspension and placebo capsule administered as single doses

Interventions

NameTypeDescription
JNJ-38431055DRUGLiquid suspension of JNJ-38431055 administered as a single dose
Sitagliptin 100 mgDRUGCapsule containing 100 mg of sitagliptin administered as a single dose
JNJ-38431055 + Sitagliptin 100 mgDRUGLiquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose
PlaceboDRUGPlacebo suspension and placebo capsule administered as single doses
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Eligibility Criteria

Age Range19 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive) * Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests * Men must agree to use a double barrier method of birth control (e.g., condom fo...

Countries:United States
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Frequently asked questions about JNJ-38431055

What is JNJ-38431055 used for?

JNJ-38431055 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It is in Phase 1 clinical development, and it has been studied in healthy male volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes JNJ-38431055?

JNJ-38431055 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical trials for Type 2 Diabetes Mellitus.

What phase is JNJ-38431055 in?

JNJ-38431055 is in Phase 1 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy male volunteers.

What clinical trials is JNJ-38431055 in?

JNJ-38431055 has been studied in two completed Phase 1 clinical trials. NCT00910923 evaluated its safety, tolerability, pharmacokinetics, and pharmacodynamics in 37 healthy male volunteers. NCT01054118 evaluated single doses of JNJ-38431055, sitagliptin, and their co-administration in 18 healthy male volunteers in the United States.

Is JNJ-38431055 the same as sitagliptin?

No, JNJ-38431055 is not the same as sitagliptin. Sitagliptin is a separate drug that was used as a comparator in a clinical trial (NCT01054118) to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of JNJ-38431055, sitagliptin, and their co-administration.