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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Drug Drug Interactions

Treatments

Drug: FOSTAMATIN

Drug: Verapamil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01197781

D4300C00011

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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