Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
Primary Purpose
Impulsive Aggression Comorbid With ADHD
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
SPN-810M
Sponsored by
About this trial
This is an interventional treatment trial for Impulsive Aggression Comorbid With ADHD focused on measuring Impulsive Aggression, ADHD
Eligibility Criteria
Key Entry:
- Healthy males.
- Aged 30 to 55 years.
- Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram.
- Able to voluntarily provide written informed consent to participate in the study.
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPN-810M
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Whole blood and plasma partitioning of total radioactivity.
To determine whole blood and plasma partitioning of total radioactivity
Pharmacokinetics (PK) of total radioactivity in plasma.
PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
PK of SPN-810 in plasma.
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.
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
To characterize and identify the metabolites of SPN-810 in plasma, urine and feces.
Safety and tolerability of SPN-810.
To assess the safety and tolerability of SPN-810 by collecting Adverse Events.
Full Information
NCT ID
NCT02023606
First Posted
December 17, 2013
Last Updated
May 12, 2016
Sponsor
Supernus Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02023606
Brief Title
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Aggression Comorbid With ADHD
Keywords
Impulsive Aggression, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPN-810M
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SPN-810M
Primary Outcome Measure Information:
Title
Urinary and fecal recoveries (mass balance) of total radioactivity.
Description
C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).
Time Frame
10 days post dose.
Secondary Outcome Measure Information:
Title
Whole blood and plasma partitioning of total radioactivity.
Description
To determine whole blood and plasma partitioning of total radioactivity
Time Frame
10 days post dose.
Title
Pharmacokinetics (PK) of total radioactivity in plasma.
Description
PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time Frame
10 days post dose.
Title
PK of SPN-810 in plasma.
Description
PK of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time Frame
10 days post dose.
Title
PK of the major metabolites of SPN-810 in plasma.
Description
PK of the major metabolites of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
Time Frame
10 days post dose.
Title
Metabolites of SPN-810 in plasma, urine and feces
Description
To characterize and identify the metabolites of SPN-810 in plasma, urine and feces.
Time Frame
10 days post dose.
Title
Safety and tolerability of SPN-810.
Description
To assess the safety and tolerability of SPN-810 by collecting Adverse Events.
Time Frame
10 days post dose.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Entry:
Healthy males.
Aged 30 to 55 years.
Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram.
Able to voluntarily provide written informed consent to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Collier, MBChB
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
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