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SSP-002358 Drug Interaction Study With Omeprazole

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: August 10, 2011
Last updated: June 6, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Healthy Drug: SSP-002358 Drug: SSP-002358 + omeprazole Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Randomized, 2-period Crossover Drug Interaction Study in Healthy Adult Subjects to Evaluate the Effect of the Proton Pump Inhibitor Omeprazole on the Pharmacokinetics of SSP-002358

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ]
    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.

  • Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 [ Time Frame: Assessed over 48 hours post-dose ]
    Area under the plasma concentration versus time curve from time 0 to infinity. 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.

Enrollment: 42
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSP-002358 alone Drug: SSP-002358
1 mg, oral, once
Experimental: SSP-002358 + omeprazole
SSP-002358 + omeprazole
Drug: SSP-002358 + omeprazole
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01415349

PRA International
Zuidlaren, Netherlands
Sponsors and Collaborators
Study Director: Patrick Martin Shire
  More Information

Responsible Party: Shire Identifier: NCT01415349     History of Changes
Other Study ID Numbers: SPD557-101
2011-001565-41 ( EudraCT Number )
Study First Received: August 10, 2011
Results First Received: June 1, 2012
Last Updated: June 6, 2014

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017