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

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SSP-004184SS; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01979185

SPD602-114

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Simvastatin

Active Comparator group

Description:

Administered as a single oral 20 mg dose on Day 1.

Treatment:

Drug: Simvastatin

Simvastatin + SSP-004184SS

Experimental group

Description:

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

Treatment:

Drug: Simvastatin

Drug: SSP-004184SS