Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil
1 other identifier
interventional
15
1 country
1
Brief Summary
This Study evaluates the possible drug interaction between FosD and verapamil when taken together.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
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
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 8, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 23, 2010
November 1, 2010
1 month
September 8, 2010
November 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD
Secondary Outcomes (1)
To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Screening, throughout both treatment periods, and follow-up.
Study Arms (2)
Period 1
EXPERIMENTALPeriod 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
- Females must be of non-childbearing potential
You may not qualify if:
- History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
- Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
- Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
- Current smokers or use of nicotine products within 1 month prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Recruiting Site
Overland Park, Kansas, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Layton, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Carlos Prendes, MD
Quintiles, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2010
First Posted
September 9, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 23, 2010
Record last verified: 2010-11