SSP-002358 Drug Interaction Study With Omeprazole

• Status: Completed
• Trial end date: 2011-09-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shire
• Treatments: Omeprazole

Criteria

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.