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

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

Study Overview

• Status: Completed
• Conditions: Impulsive Aggression Comorbid With ADHD
• Intervention / Treatment: Drug: SPN-810M

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: SPN-810M

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary and fecal recoveries (mass balance) of total radioactivity.	C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).	10 days post dose.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Jo Collier, MBChB, Quotient Clinical

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: ADHD; Impulsive Aggression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Impulsive Behavior
• Other Study ID Numbers: 810P111