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Completed

NCT Number: NCT01979185

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

SSP-004184SS

Drug

Other names: SPD602

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin

    Time frame: 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.

  2. Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin

    Time frame: 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.

  3. Maximum Plasma Concentration (Cmax) of Simvastatin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label, Cross-over Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Simvastatin in Healthy Adult Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2013
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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