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Completed

NCT Number: NCT01415349

SSP-002358 Drug Interaction Study With Omeprazole

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International

Zuidlaren, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Any known or suspected intolerance or hypersensitivity to the investigational product or omeprazole, closely related compounds, or any of the stated ingredients.

Treatment and study plan

SSP-002358

Drug

1 mg, oral, once

SSP-002358 + omeprazole

Drug

SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2011
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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