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JNJ-31001074; ketoconazole

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Apr 30, 2010

JNJ-31001074; ketoconazole development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

JNJ-31001074; ketoconazole clinical trials

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
HealthyUnlock trial analytics

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?

JNJ-31001074 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 drug interaction trial in healthy volunteers, and no approved indication has been disclosed for it. The compound remains in early clinical development.

Who is developing JNJ-31001074?

JNJ-31001074 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 drug interaction study of the compound in healthy volunteers.

What phase is JNJ-31001074 in?

JNJ-31001074 is in Phase 1 clinical development. Its only listed trial, NCT00915746, was a Phase 1 drug interaction study that has been completed. The drug is investigational and has not been approved for any indication.

What clinical trials is JNJ-31001074 in?

JNJ-31001074 has been evaluated in one clinical trial, NCT00915746, titled A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers. The Phase 1 study enrolled 14 healthy participants, was uncontrolled, and is now completed.

Is JNJ-31001074 the same as ketoconazole?

No. JNJ-31001074 and ketoconazole are separate compounds. Ketoconazole was used as the interacting drug in the Phase 1 study NCT00915746, which examined how the two agents affect each other in healthy volunteers. JNJ-31001074 is the investigational agent developed by Johnson & Johnson.

What was studied in the JNJ-31001074 drug interaction trial?

Trial NCT00915746 studied drug interactions and pharmacokinetics of JNJ-31001074 when given with ketoconazole in healthy volunteers. The Phase 1 study enrolled 14 participants aged 18 years and older, was uncontrolled, and has been completed.