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

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion (AME) of [14C] Labeled SPN-810M in Healthy Adult Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02023606

Enrollment

Registered

2013-12-30

Start date

2013-11-30

Completion date

2013-12-31

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impulsive Aggression Comorbid With ADHD

Keywords

Impulsive Aggression, ADHD

Brief summary

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

Interventions

DRUGSPN-810M

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Pharmacokinetics (PK) of total radioactivity in plasma.	10 days post dose.	PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
PK of SPN-810 in plasma.	10 days post dose.	PK of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Whole blood and plasma partitioning of total radioactivity.	10 days post dose.	To determine whole blood and plasma partitioning of total radioactivity
Metabolites of SPN-810 in plasma, urine and feces	10 days post dose.	To characterize and identify the metabolites of SPN-810 in plasma, urine and feces.
Safety and tolerability of SPN-810.	10 days post dose.	To assess the safety and tolerability of SPN-810 by collecting Adverse Events.
PK of the major metabolites of SPN-810 in plasma.	10 days post dose.	PK of the major metabolites of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026