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JNJ-39393406

Phase 2

Depression | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: May 22, 2020

JNJ-39393406 development status

Highest phase Phase 2 (NCT02677207)
Phase scored for JNJPhase 1
Registered trials 4 across 3 sponsors since Jun 2010

JNJ-39393406 target and mechanism

Molecular targetCHRNA7
Target classPositive Allosteric Modulator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment92

FDA Designations

No designations recorded

JNJ-39393406 clinical trials

JNJ-39393406 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT02677207The Effects of JNJ-39393406 on Psychometric Performance and Residual DepressiveDepression
COMPLETED80 Analytics
PHASE2COMPLETED
The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition
two weeks - each study visit

Brief Assessment of Cognition (BACS)

Plasma concentration of JNJ39393406
At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose
Cerebral spinal fluid (CSF) concentration of JNJ39393406
At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose

Secondary Endpoints

To evaluate the effects of JNJ-39393406 on depressive symptoms
two weeks - each study visit
To evaluate the effects of JNJ-39393406 on residual depressive symptoms
two weeks - each study visit
Incidence of adverse events as a measure of safety and tolerability
Approximately 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-39393406EXPERIMENTAL2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.
PlaceboPLACEBO_COMPARATOR2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.

Interventions

NameTypeDescription
JNJ-39393406DRUGJNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
PlaceboDRUGJNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Meet DSM V criteria for history of MDD or BPD by MINI. 2. Between 18-50 years of age, male or female subjects of any race, smokers and non-smokers. 3. Able to provide informed consent. All participant patients must have signed an informed consent document indicating they unde...

Countries:MoldovaRomania
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Frequently asked questions about JNJ-39393406

What is JNJ-39393406?

JNJ-39393406 is an investigational small molecule being developed by Johnson & Johnson for depression. It is a positive allosteric modulator of CHRNA7, the alpha-7 nicotinic acetylcholine receptor. It has been studied in early-stage clinical trials, including a Phase 2 study in depression and a Phase 1 pharmacokinetic study in healthy volunteers.

What is JNJ-39393406 used for?

JNJ-39393406 is being studied for depression. A completed Phase 2 trial evaluated its effects on psychometric performance and residual depressive symptoms in adults with depression. It is investigational and has not been approved for any indication.

What does JNJ-39393406 target?

JNJ-39393406 targets CHRNA7, the gene encoding the alpha-7 nicotinic acetylcholine receptor. It acts as a positive allosteric modulator, meaning it enhances receptor activity rather than directly activating the receptor itself. This mechanism is being explored in the context of depression.

Who is developing JNJ-39393406?

JNJ-39393406 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound, also known as JNJ 39393406, is part of the company's psychiatry pipeline.

What phase is JNJ-39393406 in?

JNJ-39393406 is in Phase 1 development overall, though it has also been tested in a Phase 2 trial. It is investigational and has not received FDA approval. Two trials have been completed, and no trials are currently active.

What clinical trials has JNJ-39393406 been studied in?

JNJ-39393406 has been studied in two completed trials. NCT02677207 was a Phase 2 trial of 80 participants with depression in Moldova and Romania. NCT01556217 was a Phase 1 pharmacokinetic study of 12 healthy volunteers aged 50 and older, examining cerebrospinal fluid levels.

Is JNJ-39393406 the same as JNJ 39393406?

Yes, JNJ-39393406 and JNJ 39393406 refer to the same investigational compound. The 30 mg solution is a specific formulation used in studies. All of these names identify the same CHRNA7 positive allosteric modulator being developed by Johnson & Johnson for depression.