Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01387308

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Fostamatinib Drug: Fostamatinib Drug: Fostamatinib Drug: Fostamatinib Drug: Fostamatinib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

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) [From Pre-dose until 96 hours post dose of each treatment period]
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) [From pre-dose until 96 hours post dose of each treatment period]
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 [From pre-dose until 96 hours post dose of each treatment period]
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. [From pre-dose until 96 hours post dose of each treatment period]
Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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