Trials Sponsors Conditions Drugs Pricing

Conditions

Impulsive Aggression Comorbid With ADHD

Keywords

Impulsive AggressionADHD

Outcome Measures

Primary Outcomes (1)

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 Outcomes (6)

Whole blood and plasma partitioning of total radioactivity.
10 days post dose.
Pharmacokinetics (PK) of total radioactivity in plasma.
10 days post dose.
PK of SPN-810 in plasma.
10 days post dose.
PK of the major metabolites of SPN-810 in plasma.
10 days post dose.
Metabolites of SPN-810 in plasma, urine and feces
10 days post dose.
+1 more secondary outcomes

Study Arms (1)

SPN-810M

EXPERIMENTAL

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

Interventions

SPN-810MDrug

SPN-810M

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 55 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Supernus Pharmaceuticals, Inc.
Industrylead

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

Jo Collier, MBChB
Quotient Clinical
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

December 30, 2013

Study Start

November 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

SPN-810M

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

SPN-810M

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations