SSP-002358 Drug Interaction Study With Omeprazole

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-11

Study Completion Date

2011-09-28

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSP-002358 alone

Group Type EXPERIMENTAL

SSP-002358

Intervention Type DRUG

1 mg, oral, once

SSP-002358 + omeprazole

Group Type EXPERIMENTAL

SSP-002358 + omeprazole

Intervention Type DRUG

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

Interventions

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SSP-002358

1 mg, oral, once

Intervention Type DRUG

SSP-002358 + omeprazole

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes