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MCC-based 13% drug loaded

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 19, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

MCC-based 13% drug loaded · 1 trial · 1 indication

Phase 1 1
NCT01645085A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of FostamatinibHealthy Volunteers
COMPLETED88 Analytics
PHASE1COMPLETED
A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib
Healthy Volunteers
NCT0164508588
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Study Endpoints

Primary Endpoints

Bioequivalence of R406 when fostamatinib is administered as two 50mg MCC-based 13% drug-loaded tablets versus one 100mg mannitol-based 38% drug-loaded tablet
Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Bioequivalence of R406 when fostamatinib is administered as three 50mg MCC-based 13% drug-loaded tablets versus one 150mg mannitol-based 38% drug-loaded tablet
Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

Secondary Endpoints

AUC for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Cmax for mannitol-based 38% drug-loaded tablets and MCC-based 13% drug-loaded tablets
Measured at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdoses
Frequency of adverse events
Measured throughout the study and 3 -5 days after discharge from Period 4, approximately 45 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL100mg MCC-based 13% drug-loaded tablets
Treatment BEXPERIMENTAL100mg mannitol-based 38% drug-loaded tablets
Treatment CEXPERIMENTAL150mg MCC-based 13% drug-loaded tablets
Treatment DEXPERIMENTAL150mg mannitol-based 38% drug-loaded tablets

Interventions

NameTypeDescription
MCC-based 13% drug loaded tabletsDRUG50mg tablets, dosed as 2 tablets (100mg total)
Mannitol-based 38% drug-loaded tabletDRUGOne 100mg tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and nonlactating, non childbearing potential females from 18 to 55 years, inclusive and with a weight of at least 50 kg and BMI between 18 and 30 kg/m2, inclusive * Females must have a negative pregnancy test at screening and on admission to the study center of each peri...

Countries:United States
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Frequently asked questions about MCC-based 13% drug loaded

What is MCC-based 13% drug loaded?

MCC-based 13% drug loaded is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug has been studied in a completed clinical trial with 88 participants.

What does MCC-based 13% drug loaded target?

The specific molecular target of MCC-based 13% drug loaded has not been disclosed in available information. The drug is a small molecule modality, but its mechanism of action is not publicly detailed.

Who makes MCC-based 13% drug loaded?

MCC-based 13% drug loaded is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is publicly traded under the ticker symbol AZN on major stock exchanges.

What phase is MCC-based 13% drug loaded in?

MCC-based 13% drug loaded is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is MCC-based 13% drug loaded in?

MCC-based 13% drug loaded has been studied in one completed clinical trial, NCT01645085. This was a Phase 1 study assessing the bioequivalence of R406 in healthy volunteers when given 100mg and 150mg of fostamatinib. The trial enrolled 88 participants in the United States.

Is MCC-based 13% drug loaded the same as fostamatinib?

MCC-based 13% drug loaded is associated with fostamatinib, as the completed clinical trial NCT01645085 evaluated the bioequivalence of R406, the active metabolite of fostamatinib, when administered as 100mg and 150mg doses. However, the drug name itself does not explicitly indicate this relationship.