SSP-002358 Drug Interaction Study With Omeprazole

Shire42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SSP-002358DRUG

1 mg, oral, once

SSP-002358 + omeprazoleDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PRA International

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Maximum Plasma Concentration (Cmax) for SSP-002358

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.

Time frame: Assessed over 48 hours post-dose

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358

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.

Time frame: Assessed over 48 hours post-dose

Data from ClinicalTrials.gov

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