Phase 1
Completed N=6
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT01786876 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358 — 43476 pg*h/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358 |
43476 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358 |
4643 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358 |
1.25 | — |
| PRIMARY Plasma Half-Life (T1/2) of Radiolabelled SSP-002358 |
11.0 | — |
| PRIMARY AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |
101960 | — |
| PRIMARY Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |
9252 | — |
| PRIMARY Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |
2.00 | — |
| PRIMARY Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |
6.96 | — |
| PRIMARY AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358 |
137314 | — |
| PRIMARY Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358 |
11658 | — |
| PRIMARY Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358 |
1.50 | — |
| PRIMARY Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358 |
10.9 | — |
| PRIMARY Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358 |
38.2 | — |
| PRIMARY Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358 |
57.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01786876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.