A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

Brief Summary

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A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different Formulations of Fostamatinib.

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Detailed Description

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An Open-label, Single-center, Randomized, 4-way Crossover Study to Assess the Bioequivalence of R406 in Healthy Volunteers when 100 and 150mg of Fostamatinib are Administered as the 13% Drug-loaded Tablet Versus the 38% Drug-loaded Tablet.

Treatment sequences will be determined using two 2-2 crossover designs in sequence, 1 for treatments A and B, and 1 for treatments C and D. The order of the designs containing AB/BA and CD/DC within the overall design, as well as the order of treatments within each design, will be randomized. This gives a total of 8 possible treatment sequences as follows: ABCD, ABDC, BACD, BADC, CDAB, CDBA, DCAB, DCBA.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

100mg MCC-based 13% drug-loaded tablets

Group Type EXPERIMENTAL

MCC-based 13% drug loaded tablets

Intervention Type DRUG

50mg tablets, dosed as 2 tablets (100mg total)

Treatment B

100mg mannitol-based 38% drug-loaded tablets

Group Type EXPERIMENTAL

Mannitol-based 38% drug-loaded tablet

Intervention Type DRUG

One 100mg tablet

Treatment C

150mg MCC-based 13% drug-loaded tablets

Group Type EXPERIMENTAL

MCC-based 13% drug loaded tablets

Intervention Type DRUG

3 tablets (150mg total)

Treatment D

150mg mannitol-based 38% drug-loaded tablets

Group Type EXPERIMENTAL

Mannitol-based 38% drug-loaded tablet

Intervention Type DRUG

One 150 mg tablet

Interventions

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MCC-based 13% drug loaded tablets

50mg tablets, dosed as 2 tablets (100mg total)

Intervention Type DRUG

Mannitol-based 38% drug-loaded tablet

One 100mg tablet

Intervention Type DRUG

MCC-based 13% drug loaded tablets

3 tablets (150mg total)

Intervention Type DRUG

Mannitol-based 38% drug-loaded tablet

One 150 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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 period, must not be lactating and must be of non childbearing potential
* Non childbearing potential can be confirmed by being postmenopausal defined as amenorrhea for a least 12 months following cessation of all exogenous hormonal treatments and with FSH and LH levels in the laboratory-defined postmenopausal range
* Non childbearing potential can be confirmed by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.

Exclusion Criteria

* History of any clinically significant disease or disorder, including GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
* Known or suspected history of drug abuse, as judge by the investigator
* Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
* Current smokers, or those who have smoked, used nicotine-containing products, or used smoking cessation treatments within the previous 1 month prior to enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes