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

Phase 1

Completed

• Conditions: Drug Drug Interactions; Healthy Volunteers
• Interventions: Drug: FOSTAMATIN; Drug: Verapamil

• Registration Number: NCT01197781
• Lead Sponsor: AstraZeneca

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-19
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1	FOSTAMATIN	-
Period 2	FOSTAMATIN	-
Period 2	Verapamil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Recruiting Site; 🇺🇸 Overland Park, Kansas, United States