Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Simvastatin; Drug: SSP-004184SS

• Registration Number: NCT01979185
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Study Start: 2013-11-18
• Primary Completion: 2013-12-13
• Study Completion: 2013-12-13
• Results First Submitted: 2014-12-16
• Results First Submitted QC: 2014-12-16
• Results First Posted: 2014-12-24
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Simvastatin + SSP-004184SS	Simvastatin	Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Simvastatin	Simvastatin	Administered as a single oral 20 mg dose on Day 1.
Simvastatin + SSP-004184SS	SSP-004184SS	Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin	Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.	AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. 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.
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin	Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.	AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. 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.
Maximum Plasma Concentration (Cmax) of Simvastatin	Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Trial Locations

Locations (1)

Clinical Pharmacology of Miami, Inc.; 🇺🇸 Miami, Florida, United States