SSP-002358 Drug Interaction Study With Omeprazole

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SSP-002358; Drug: SSP-002358 + omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415349

2011-001565-41 (EudraCT Number)

SPD557-101

Details and patient eligibility

About

This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-55 years inclusive at the time of consent.

2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

   • Male, or
   • Non-pregnant, non-lactating female
   • Females must be at least 90 days post-partum or nulliparous.

Exclusion criteria

1. Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments.
2. Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

SSP-002358 alone

Experimental group

Treatment:

Drug: SSP-002358

SSP-002358 + omeprazole

Experimental group

Description:

SSP-002358 + omeprazole

Treatment:

Drug: SSP-002358 + omeprazole