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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fostamatinib

• Registration Number: NCT01387308
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-04
• Study Start: 2011-08
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Fostamatinib	Fostamatinib 50 mg tablet x 2 (Phase 3 batch)
B	Fostamatinib	Fostamatinib 50 mg tablet x 3 (Phase 3 batch)
C	Fostamatinib	Fostamatinib 100 mg tablet (new formulation)
D	Fostamatinib	Fostamatinib 150 mg tablet (new formulation)
E	Fostamatinib	Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States