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JNJ-31001074; ketoconazole

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 30, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-31001074; ketoconazole · 1 trial · 3 indications

Phase 1 1
NCT00915746A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy VolunteersHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
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Study Endpoints

Primary Endpoints

The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers
Multiple blood samples will be obtained over the 11 day open-label treatment phase

Secondary Endpoints

To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole
up to 32 days (including a 21 day screening phase)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Interventions

NameTypeDescription
JNJ-31001074; ketoconazoleDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * healthy volunteer between the ages of 18-55 * if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test * body mass index between 18-30 * body weight greater than or equal to 50 kilograms * blood pressure b...

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Frequently asked questions about JNJ-31001074; ketoconazole

What is JNJ-31001074 used for?

JNJ-31001074 is an investigational small molecule being studied in healthy volunteers for pharmacokinetics and drug interactions. It was evaluated in a Phase 1 clinical trial to assess its interaction with ketoconazole. The drug is not approved and remains in clinical development.

What does JNJ-31001074 target?

The molecular target of JNJ-31001074 has not been disclosed. It is a small molecule being studied for its pharmacokinetic properties and potential drug interactions in healthy volunteers. No specific target or mechanism of action has been reported for this investigational compound.

Who makes JNJ-31001074?

JNJ-31001074 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The compound is an investigational small molecule that has been studied in early-stage clinical trials.

What phase is JNJ-31001074 in?

JNJ-31001074 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an uncontrolled, non-randomized study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is JNJ-31001074 in?

JNJ-31001074 has been studied in one completed clinical trial, NCT00915746, titled 'A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers.' This Phase 1 study enrolled 14 participants and evaluated the drug's pharmacokinetics and interaction with ketoconazole.

Is JNJ-31001074 the same as ketoconazole?

No, JNJ-31001074 is not the same as ketoconazole. JNJ-31001074 is an investigational small molecule being developed by Johnson & Johnson, while ketoconazole is an antifungal medication. The two were studied together in a clinical trial to assess potential drug interactions.