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MCC-based 13% drug loaded

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Mar 19, 2013

MCC-based 13% drug loaded target and mechanism

ModalitySmall molecule

Also known as MCC-based 13% drug loaded tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

MCC-based 13% drug loaded clinical trials

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 VolunteersUnlock trial analytics

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 formulation developed by AstraZeneca PLC. It is described as MCC-based 13% drug loaded tablets. The formulation has been studied in a Phase 1 clinical trial in healthy volunteers, and its specific therapeutic indication has not been disclosed.

Who makes MCC-based 13% drug loaded?

MCC-based 13% drug loaded is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this formulation.

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

MCC-based 13% drug loaded is in Phase 1 clinical development. It is an investigational formulation and has not been approved by the FDA. The Phase 1 program includes one completed trial with 88 participants.

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

MCC-based 13% drug loaded has been evaluated in one clinical trial, NCT01645085, titled "A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib." This Phase 1 trial was completed, enrolled 88 healthy volunteers, and was conducted in the United States.

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

Yes, MCC-based 13% drug loaded tablets is another name for MCC-based 13% drug loaded. Both terms refer to the same investigational formulation developed by AstraZeneca PLC.