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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Radiolabeled SPD557

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiolabeled SPD557	Drug: Radiolabeled SPD557; A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358	Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.	Over 240 hours post-dose
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.	Over 240 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358		Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358		Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358		Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358		Over 240 hours post-dose

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General Publications

• Flach S, Croft M, Ding J, Budhram R, Pankratz T, Pennick M, Scarfe G, Troy S, Getsy J. Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2013
• Primary Completion (Actual): April 12, 2013
• Study Completion (Actual): April 12, 2013

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: AME; Radiolabelled
• Other Study ID Numbers: SPD557-107