SSP-002358 Drug Interaction Study With Omeprazole

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SSP-002358; Drug: SSP-002358 + omeprazole

• Registration Number: NCT01415349
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study Start: 2011-08-11
• Study First Posted: 2011-08-11
• Primary Completion: 2011-09-28
• Study Completion: 2011-09-28
• Results First Submitted: 2012-06-01
• Results First Submitted QC: 2012-06-01
• Results First Posted: 2012-07-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SSP-002358 alone	SSP-002358	-
SSP-002358 + omeprazole	SSP-002358 + omeprazole	SSP-002358 + omeprazole

Primary Outcome Measures

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

Trial Locations

Locations (1)

PRA International; 🇳🇱 Zuidlaren, Netherlands