Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989169

SPD602-117

Details and patient eligibility

About

A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam 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 between the ages of 18 and 65, inclusive
• 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

Midazolam

Active Comparator group

Description:

Administered as a single oral 6 mg dose on Day 1.

Treatment:

Drug: Midazolam

SSP-004184SS + Midazolam

Experimental group

Description:

Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.

Treatment:

Drug: SSP-004184SS

Drug: Midazolam