A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Radiolabeled SPD557
- Conditions
- Healthy Volunteers
- Sponsor
- Shire
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Radiolabeled SPD557
Intervention: Radiolabeled SPD557
Outcomes
Primary Outcomes
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358
Time Frame: 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
Time Frame: Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Time Frame: Over 240 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358
Time Frame: 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.