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

Phase 1

Completed

• Conditions: Impulsive Aggression Comorbid With ADHD
• Interventions: Drug: SPN-810M

• Registration Number: NCT02023606
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPN-810M	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Whole blood and plasma partitioning of total radioactivity.	10 days post dose.	To determine whole blood and plasma partitioning of total radioactivity
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).
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).
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.

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Ruddington, Nottingham, United Kingdom