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31001074/paroxetine

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 8, 2014

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

31001074/paroxetine · 1 trial · 1 indication

Phase 1 1
NCT01159821A Drug Interaction Study of 31001074 and Paroxetine in Healthy VolunteersHealthy
COMPLETED14 Analytics
PHASE1COMPLETED
A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
Healthy
NCT0115982114
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Study Endpoints

Primary Endpoints

Pharmacokinetic parameters (area under the plasma concentration-time curve [AUC] and the maximum plasma concentration [Cmax]) of 31001074 with and without the coadministration of paroxetine
0 to 72 hours after study drug administration on Day 1 and Day 13

Secondary Endpoints

The number and type of adverse events and serious adverse events reported
From screening (up to 29 days before study drug administration) through 30 days after Day 16 (study completion) or at the time of early withdrawal from the study
Results from clinical laboratory tests performed
During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
Findings from electrocardiograms (ECGs) and vital signs measurements performed
During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
001EXPERIMENTAL31001074/paroxetine 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15

Interventions

NameTypeDescription
31001074/paroxetineDRUG1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a body mass index (BMI) (weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg * Have a blood pressure after the healthy volunteer is supine \[ie, lying down face up\] for 5 minutes between 90 and 140 mmHg systolic, inclusi...

Countries:United States
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Frequently asked questions about 31001074/paroxetine

What is 31001074/paroxetine used for?

31001074/paroxetine is an investigational small molecule being studied in healthy volunteers. The only clinical trial listed is a drug interaction study of 31001074 and paroxetine in healthy volunteers, so it is not being developed for a specific disease indication at this stage.

Who makes 31001074/paroxetine?

Johnson & Johnson (NYSE: JNJ) is developing 31001074/paroxetine. The drug is an investigational small molecule currently in early clinical development.

What phase is 31001074/paroxetine in?

31001074/paroxetine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The single completed trial was a Phase 1 study in healthy volunteers.

What clinical trials is 31001074/paroxetine in?

31001074/paroxetine has one completed clinical trial, NCT01159821, titled "A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers." This Phase 1 study enrolled 14 participants in the United States and was not randomized or double-blinded.

Is 31001074/paroxetine the same as paroxetine?

31001074/paroxetine is a combination or co-administration of two agents: 31001074 and paroxetine. The clinical trial specifically studies the drug interaction between 31001074 and paroxetine in healthy volunteers, indicating they are distinct compounds being evaluated together.