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

Study Overview
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Brief Summary
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This Study evaluates the possible drug interaction between FosD and verapamil when taken together.

Detailed Description
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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.

Official Title
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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

Conditions
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Drug Drug Interactions, Healthy Volunteers

Intervention / Treatment
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* Drug: FOSTAMATIN
* Drug: Verapamil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br> | Drug: FOSTAMATIN<br>* Oral tablets - single dose<br>|
| Experimental: Period 2<br> | Drug: FOSTAMATIN<br>* Oral tablets - single dose<br>Drug: Verapamil<br>* Oral tablets - administered 3 times daily over 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, FosD, fostamatinib disodium, verapamil, healthy volunteers