Phase 1
N=6
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01824446 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184 — 251438.3 ng*hr/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Radiolabeled SPD602 (FBS0701, SSP-004184) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Shire
- Primary completion
- May 2013
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-004184 |
251438.3 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184 |
119000.0 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184 |
1.0 | — |
| PRIMARY Plasma Half-Life (T1/2) of Radiolabelled SSP-004184 |
13.039 | — |
| PRIMARY Total Body Clearance (CL/F) of Radio-Labelled SSP-004184 |
12.754 | — |
| PRIMARY Volume of Distribution (Vz/F) of Radiolabelled SSP-004184 |
216.534 | — |
| PRIMARY AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |
156702.7 | — |
| PRIMARY Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |
57216.7 | — |
| PRIMARY Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |
1.5 | — |
| PRIMARY Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |
2.863 | — |
| PRIMARY CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184 |
19.396 | — |
| PRIMARY Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |
76.731 | — |
| PRIMARY AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184 |
293626.3 | — |
| PRIMARY Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184 |
103650.0 | — |
| PRIMARY Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184 |
1.5 | — |
| PRIMARY Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184 |
9.389 | — |
| PRIMARY CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184 |
11.071 | — |
| PRIMARY Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184 |
137.108 | — |
| PRIMARY Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184 |
62.4 | — |
| PRIMARY Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184 |
29.9 | — |
Summary
To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.
Eligibility Criteria
Inclusion Criteria
- Healthy adult male subjects aged between 18 and 65 years inclusive
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01824446). 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.