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

Impulsive Aggression Comorbid With ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023606
• Other study ID #: 810P111
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2013
• Last updated: May 12, 2016
• Start date: November 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Impulsive Aggression Comorbid With ADHD

Intervention

Drug:
• SPN-810M

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Whole blood and plasma partitioning of total radioactivity.	To determine whole blood and plasma partitioning of total radioactivity	10 days post dose.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Safety and tolerability of SPN-810.	To assess the safety and tolerability of SPN-810 by collecting Adverse Events.	10 days post dose.	Yes