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SPN-810M

Phase 1

Impulsive Aggression Comorbid With ADHD | Small molecule | Psychiatry |Supernus Pharmaceuticals, Inc.|Last Updated: May 13, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

SPN-810M · 1 trial · 1 indication

Phase 1 1
NCT02023606Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810MImpulsive Aggression Comorbid With ADHD
COMPLETED7 Analytics
PHASE1COMPLETED
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
Impulsive Aggression Comorbid With ADHD
NCT020236067
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Study Endpoints

Primary Endpoints

Urinary and fecal recoveries (mass balance) of total radioactivity.
10 days post dose.

C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).

Secondary Endpoints

Whole blood and plasma partitioning of total radioactivity.
10 days post dose.
Pharmacokinetics (PK) of total radioactivity in plasma.
10 days post dose.
PK of SPN-810 in plasma.
10 days post dose.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SPN-810MEXPERIMENTALSingle dose of 20 mL solution containing 50 mg of SPN-810M and no less than 8.5 MBq (225 µCi) carbon-14 (14C)-SPN-810M, and no more than 11.3 MBq (305 µCi) \[14C\] SPN-810M.

Interventions

NameTypeDescription
SPN-810MDRUG -
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Eligibility Criteria

Age Range30 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Entry: 1. Healthy males. 2. Aged 30 to 55 years. 3. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram. 4. Able to voluntarily provide written informed consent to par...

Countries:United Kingdom
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Frequently asked questions about SPN-810M

What is SPN-810M used for?

SPN-810M is an investigational small molecule being developed for impulsive aggression comorbid with ADHD. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is intended to address impulsive aggression in patients who also have attention deficit hyperactivity disorder.

Who makes SPN-810M?

SPN-810M is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company. Supernus Pharmaceuticals is publicly traded under the ticker symbol SUPN. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of SPN-810M in the intended patient population.

What phase is SPN-810M in?

SPN-810M is in Phase 1 clinical development. A Phase 1 study has been completed to assess the absorption, metabolism, and excretion of the drug. SPN-810M is still investigational and has not received FDA approval for any indication.

What clinical trials is SPN-810M in?

SPN-810M has one completed Phase 1 clinical trial, identified as NCT02023606. This study assessed the absorption, metabolism, and excretion of [14C] labeled SPN-810M in healthy male volunteers aged 30 years and older. The trial was conducted in the United Kingdom and enrolled 7 participants.

How does SPN-810M work?

The mechanism of action for SPN-810M has not been disclosed in available information. The drug is a small molecule being studied for impulsive aggression comorbid with ADHD, but its specific molecular target has not been publicly identified.