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Completed

NCT Number: NCT02023606

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 of Radio Labeled SPN-810M in Healthy Adult Male Volunteers

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Key information

Conditions

Impulsive Aggression Comorbid With ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPN-810M

Drug

Primary outcomes

  1. Urinary and fecal recoveries (mass balance) of total radioactivity.

    Time frame: 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 outcomes

  1. Whole blood and plasma partitioning of total radioactivity.

    Time frame: 10 days post dose.

    To determine whole blood and plasma partitioning of total radioactivity

  2. Pharmacokinetics (PK) of total radioactivity in plasma.

    Time frame: 10 days post dose.

    PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).

  3. PK of SPN-810 in plasma.

    Time frame: 10 days post dose.

    PK of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).

  4. PK of the major metabolites of SPN-810 in plasma.

    Time frame: 10 days post dose.

    PK of the major metabolites of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).

  5. Metabolites of SPN-810 in plasma, urine and feces

    Time frame: 10 days post dose.

    To characterize and identify the metabolites of SPN-810 in plasma, urine and feces.

  6. Safety and tolerability of SPN-810.

    Time frame: 10 days post dose.

    To assess the safety and tolerability of SPN-810 by collecting Adverse Events.

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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