Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:12/15/2018
Start Date:March 7, 2013
End Date:April 12, 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects

Phase I study to evaluate the excretion of radioactivity, the metabolic profile,
pharmacokinetics, safety and tolerability following a single oral administration of [14C]
SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study
is to investigate how and how quickly SPD557 or its break down products are excreted by
analysing blood, faeces and urine samples collected during the study.


Key Inclusion Criteria:

- Males ages 18 to 50 years

- Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2

- Subject is willing to comply with any applicable contraceptive and sperm donation
requirements

Key Exclusion criteria:

- Have participated in a [14C]-study within the last 6 months.

- Exposure to clinically significant radiation within 12 months prior to dose (for
example, serial X-ray or computed tomography scans, barium meal, current employment in
a job requiring radiation exposure monitoring).

- Male subjects who consume more than 21 units of alcohol per week or 3 units per day.

- Subjects who report typically having more than 2 bowel movements per day, less than 3
bowel movements per week or those whose bowel habits have changed significantly within
30 days
We found this trial at
1
site
Covance, Inc.
Madison, Wisconsin 53704
?
mi
from
Madison, WI
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