Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets - Full Text View

Purpose

Study in healthy males to assess bioavailability of 4 different fostamatinib tablets.

Condition	Intervention	Phase
Healthy	Drug: Fostamatinib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Open-label, Partially Randomized, 5-way Crossover Study in Healthy Volunteers to Assess the Relative Bioavailability of 100 and 150 mg Fostamatinib Tablets Compared With 50 mg Fostamatinib Tablets

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation) [ Time Frame: From Pre-dose until 96 hours post dose of each treatment period ] [ Designated as safety issue: No ]
Assessments will include but is not limited to: plasma R406 AUC, Cmax
To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation) [ Time Frame: From pre-dose until 96 hours post dose of each treatment period ] [ Designated as safety issue: No ]
Assessments will include but is not limited to: plasma R406 AUC, Cmax )

Secondary Outcome Measures:

To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches [ Time Frame: From pre-dose until 96 hours post dose of each treatment period ] [ Designated as safety issue: Yes ]
The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions. [ Time Frame: From pre-dose until 96 hours post dose of each treatment period ] [ Designated as safety issue: No ]
Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax

Estimated Enrollment:	24
Study Start Date:	August 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Fostamatinib 50 mg tablet x 2 (Phase 3 batch)	Drug: Fostamatinib Oral tablets, 50 mg x 2, single dose
Sham Comparator: B Fostamatinib 50 mg tablet x 3 (Phase 3 batch)	Drug: Fostamatinib Oral tablets, 50 mg x 3, single dose
Experimental: C Fostamatinib 100 mg tablet (new formulation)	Drug: Fostamatinib Oral tablets, 100 mg, single dose
Experimental: D Fostamatinib 150 mg tablet (new formulation)	Drug: Fostamatinib Oral tablets, 150 mg, single dose
Experimental: E Fostamatinib 50 mg tablet x 2 (Phase 3 batch)	Drug: Fostamatinib Oral tablets, 50 mg x 2, single dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of signed and dated informed consent prior to any study specific procedures
Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

Exclusion Criteria:

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387308

Locations

United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01387308 History of Changes
Other Study ID Numbers:	D4300C00018
Study First Received:	June 30, 2011
Last Updated:	October 27, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1
Healthy male volunteers
pharmacokinetics

fostamatinib
Scientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_max
Laymen Terminology: Amount of R406 in blood

ClinicalTrials.gov processed this record on May 19, 2013