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FOSTAMATIN

Phase 1

Drug Drug Interactions | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 23, 2010

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

FOSTAMATIN · 1 trial · 2 indications

Phase 1 1
NCT01197781Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy VolunteersDrug Drug Interactions
COMPLETED15 Analytics
PHASE1COMPLETED
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
Drug Drug InteractionsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTAL -
Period 2EXPERIMENTAL -

Interventions

NameTypeDescription
FOSTAMATINDRUGOral tablets - single dose
VerapamilDRUGOral tablets - administered 3 times daily over 4 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 clin...

Countries:United States
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Frequently asked questions about FOSTAMATIN

What is FOSTAMATIN used for?

FOSTAMATIN is a small molecule being studied for its potential in drug-drug interactions. It was evaluated in a Phase 1 clinical trial involving healthy volunteers to assess how it interacts when taken together with verapamil. The study focused on healthy volunteers rather than patients with a specific disease.

Who makes FOSTAMATIN?

FOSTAMATIN is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this small molecule, with the drug currently in Phase 1 development.

What phase is FOSTAMATIN in?

FOSTAMATIN is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is FOSTAMATIN in?

FOSTAMATIN has been studied in one clinical trial with the identifier NCT01197781. This Phase 1 study, titled "Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers," was completed in the United States and enrolled 15 participants.

Is FOSTAMATIN the same as FosD?

Yes, FOSTAMATIN is also known as FosD. In the clinical trial NCT01197781, the drug is referred to as FosD, and the study evaluates the drug-drug interaction between FosD and verapamil when taken together in healthy volunteers.