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SSP-002358 Drug Interaction Study With Omeprazole

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ClinicalTrials.gov Identifier: NCT01415349
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : July 6, 2012
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SSP-002358 Drug: SSP-002358 + omeprazole Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : August 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415349


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01415349     History of Changes
Other Study ID Numbers: SPD557-101
2011-001565-41 ( EudraCT Number )
First Posted: August 11, 2011    Key Record Dates
Results First Posted: July 6, 2012
Last Update Posted: June 13, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action