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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01197781

Enrollment

Registered

2010-09-09

Start date

2010-09-30

Completion date

2010-10-31

Last updated

2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interactions, Healthy Volunteers

Keywords

Phase I, FosD, fostamatinib disodium, verapamil, healthy volunteers

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.

Interventions

DRUGFOSTAMATIN

Oral tablets - single dose

DRUGVerapamil

Oral tablets - administered 3 times daily over 4 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026