Phase 1
Completed N=30
Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
Healthy
Source: ClinicalTrials.gov NCT01979185 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin — 38.142; 26.601 ng*h/ml
Summary
This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin |
38.142; 26.601 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin |
34.351; 24.019 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Simvastatin |
5.006; 2.72 | — |
Eligibility Criteria
Inclusion Criteria
- Normal healthy male and female volunteers
- Serum ferritin, hemoglobin and erythrocyte indices within normal range
Exclusion Criteria
- Evidence of any active or chronic disease
Data sourced from ClinicalTrials.gov (NCT01979185). 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.