Clinical trial NCT01786876: Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Radiolabelled
AME
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
measure: Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
timeFrame: Over 240 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.