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

NCT ID: NCT01197781

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-10-31

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.

Conditions

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Drug Drug Interactions Healthy Volunteers

Keywords

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Phase I FosD fostamatinib disodium verapamil healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period 1

Group Type EXPERIMENTAL

FOSTAMATIN

Intervention Type DRUG

Oral tablets - single dose

Period 2

Group Type EXPERIMENTAL

FOSTAMATIN

Intervention Type DRUG

Oral tablets - single dose

Verapamil

Intervention Type DRUG

Oral tablets - administered 3 times daily over 4 days

Interventions

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FOSTAMATIN

Oral tablets - single dose

Intervention Type DRUG

Verapamil

Oral tablets - administered 3 times daily over 4 days

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Mark Layton, MD

Role: STUDY_DIRECTOR

AstraZeneca

Carlos Prendes, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Recruiting Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D4300C00011

Identifier Type: -

Identifier Source: org_study_id