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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Mar 2013
Shorter than P25 for phase_1 healthy-volunteers
1 active site
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
First Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedStudy Start
First participant enrolled
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2013
CompletedResults Posted
Study results publicly available
March 27, 2014
CompletedJune 10, 2021
May 1, 2021
1 month
February 6, 2013
February 10, 2014
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
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
Study Arms (1)
Radiolabeled SPD557
EXPERIMENTALInterventions
A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Covance
Madison, Wisconsin, 53704, United States
Related 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. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016.
PMID: 27729771RESULT
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 8, 2013
Study Start
March 7, 2013
Primary Completion
April 12, 2013
Study Completion
April 12, 2013
Last Updated
June 10, 2021
Results First Posted
March 27, 2014
Record last verified: 2021-05