SSP-002358 Drug Interaction Study With Omeprazole

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415349
• Other study ID #: SPD557-101
• Secondary ID: 2011-001565-41
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2011
• Est. completion date: September 28, 2011

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 28, 2011
• Est. primary completion date: September 28, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SSP-002358
1 mg, oral, once
• SSP-002358 + omeprazole
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once

Locations

Country	Name	City	State
Netherlands	PRA International	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed over 48 hours post-dose
Primary	Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0?8) 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.	Assessed over 48 hours post-dose