SSP-002358 Drug Interaction Study With Omeprazole
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
2 other identifiers
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Aug 2011
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2011
CompletedResults Posted
Study results publicly available
July 6, 2012
CompletedJune 10, 2021
May 1, 2021
2 months
August 10, 2011
June 1, 2012
May 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
Assessed over 48 hours post-dose
Study Arms (2)
SSP-002358 alone
EXPERIMENTALSSP-002358 + omeprazole
EXPERIMENTALSSP-002358 + omeprazole
Interventions
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
PRA International
Zuidlaren, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
August 11, 2011
Primary Completion
September 28, 2011
Study Completion
September 28, 2011
Last Updated
June 10, 2021
Results First Posted
July 6, 2012
Record last verified: 2021-05