NCT02023606

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

May 13, 2016

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

December 17, 2013

Last Update Submit

May 12, 2016

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

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

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

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

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 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 13, 2016

Record last verified: 2013-12

Locations

GB(1)