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Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Drug Interactions; Healthy Volunteers

Intervention: FOSTAMATIN (Drug); Verapamil (Drug)

Phase: Phase 1

Status: Completed

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: November 19, 2010

Page last updated: August 23, 2015

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