Recent Updates
Recently added Catalysts

JNJ-31001074

Phase 2

Attention Deficit Hyperactivity Disorder | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 13, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-31001074 · 4 trials · 4 indications

Phase 2 1Phase 1 3
NCT00566449A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.Attention Deficit Hyperactivity Disorder
COMPLETED32 Analytics
PHASE2COMPLETED
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
Attention Deficit Hyperactivity Disorder
NCT0056644932
Unlock trial analytics

Study Endpoints

Primary Endpoints

The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
To characterize the pharmacokinetics of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg JNJ-31001074 and to quantify the effect of food on the pharmacokinetics of 10 mg JNJ-31001074.
Multiple blood and urine samples will be collected for 72 hours after dosing of JNJ-31001074 in each of the 4 treatment periods
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of JNJ-31001074 after a single dose administration of JNJ-31001074 in pediatric patients with ADHD, 6 to 11 years of age, inclusive.
3 days of blood and urine sampling
The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of JNJ-31001074 after a single dose administration of JNJ-31001074 in pediatric patients with ADHD, 12 to 17 years of age, inclusive.
3 days of blood and urine sampling

Secondary Endpoints

The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
To evaluate the safety and tolerability of JNJ-31001074
up to 66 days (including 21 day screening period)
To assess pharmacokinetic dose proportionality of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg
up to 66 days (including 21 day screening period)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-31001074 10 mg daily for 4 weeks
003PLACEBO_COMPARATORPlacebo one dose daily for 4 weeks
002EXPERIMENTALJNJ-31001074 30 mg daily for 4 weeks

Interventions

NameTypeDescription
PlaceboDRUGone dose daily for 4 weeks
JNJ-31001074DRUG10 mg daily for 4 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7 * In good general health * Willing to not take any other ADHD medication or start any behaviorial modification programs during the study * Willing to use approved birth control throughout the study ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about JNJ-31001074

What is JNJ-31001074 used for?

JNJ-31001074 is an investigational small molecule being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients. It has also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development and is not approved for any use.

Who makes JNJ-31001074?

JNJ-31001074 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored clinical trials of the drug in patients with ADHD and in healthy volunteers.

What phase is JNJ-31001074 in?

JNJ-31001074 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in adults with ADHD. All three completed trials are finished, and the drug remains investigational with no approved indication.

What clinical trials has JNJ-31001074 been in?

JNJ-31001074 has been studied in three completed trials. NCT00566449 was a Phase 2 safety and effectiveness study in adults with ADHD. NCT00890240 and NCT00890292 were Phase 1 pharmacokinetic studies in children aged 6-11 and 12-17 with ADHD. NCT00915434 evaluated the drug in healthy volunteers.

Is JNJ-31001074 the same as any other drug?

No alternative names for JNJ-31001074 have been disclosed. The drug is identified only by its development code JNJ-31001074 in clinical trial records. It is a distinct investigational compound being developed by Johnson & Johnson.