Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Drug Interactions; Healthy Volunteers
Intervention: FosD (Drug); Verapamil (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Mark Layton, MD, Study Director, Affiliation: AstraZeneca
Carlos Prendes, MD, Principal Investigator, Affiliation: Quintiles
Summary
This Study evaluates the possible drug interaction between FosD and verapamil when taken
together.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: 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.
Secondary outcome: To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Recruiting Site, Overland Park, Kansas, United States
Additional Information
Starting date: September 2010
Last updated: September 8, 2010
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