SSP-002358 Drug Interaction Study With Omeprazole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01415349
First received: August 10, 2011
Last updated: June 6, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01415349

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

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01415349     History of Changes
Other Study ID Numbers: SPD557-101, 2011-001565-41
Study First Received: August 10, 2011
Results First Received: June 1, 2012
Last Updated: June 6, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on July 31, 2014