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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Radiolabeled SPD557

• Registration Number: NCT01786876
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Study Start: 2013-03-07
• Primary Completion: 2013-04-12
• Study Completion: 2013-04-12
• Results First Submitted: 2014-02-10
• Results First Submitted QC: 2014-02-10
• Results First Posted: 2014-03-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiolabeled SPD557	Radiolabeled SPD557	-

Primary Outcome Measures

Name	Time	Method
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
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358	Over 240 hours post-dose	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.
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
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358	Over 240 hours post-dose	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.

Trial Locations

Locations (1)

Covance; 🇺🇸 Madison, Wisconsin, United States