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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786876
• Other study ID #: SPD557-107
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2013
• Est. completion date: April 12, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 12, 2013
• Est. primary completion date: April 12, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Radiolabeled SPD557
A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Locations

Country	Name	City	State
United States	Covance	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0?8) 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
Primary	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
Primary	Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Plasma Half-Life (T1/2) of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	AUC 0?8 Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	AUC 0?8 Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358		Over 240 hours post-dose
Primary	Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358		Over 240 hours post-dose