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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Impulsive Aggression Comorbid With ADHD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPN-810M

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.

Group Type EXPERIMENTAL

SPN-810M

Intervention Type DRUG

Interventions

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SPN-810M

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes