A Study to Assess the Bioequivalence of R406 in Healthy Volunteers When Given 100mg and 150 mg of Fostamatinib
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | July 2012 |
End Date: | October 2012 |
Contact: | Quintiles Overland Park Volunteer Recruitment |
Phone: | 913-894-5533 |
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
A study in Healthy Volunteers to Compare the Amount of R406 in Blood When Given Different
Formulations of Fostamatinib.
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.
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
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