Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

Supernus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Impulsive Aggression Comorbid With ADHD

Treatments: Drug: SPN-810M

Study type: Interventional

Funder types: Industry

Identifiers

NCT02023606

810P111

Details and patient eligibility

About

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers

Enrollment: 7 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 participate in the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

SPN-810M

Experimental group

Description:

Single 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.

Treatment:

Drug: SPN-810M