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

Phase 1

Completed

• Conditions: Pharmacokinetics; Bioavailability
• Interventions: Drug: Fostamatinib

• Registration Number: NCT01208155
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

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

Inclusion Criteria

• Weight of at least 50 kg and body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
• Volunteers must be willing to use barrier contraception ie, condoms, from the Day 1 of Treatment Period 1 until 2 weeks after the final dosing of the investigational product (IP)

Exclusion Criteria

• History of any clinically significant disease or disorder
• History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug
• Volunteers who smoke more than 5 cigarettes or the equivalent in tobacco per day
• Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	Fostamatinib	Fostamatinib 100 mg tablet (batch 4)
1	Fostamatinib	Fostamatinib 50 mg tablet x 2
2	Fostamatinib	Fostamatinib 100 mg tablet (batch 1)
3	Fostamatinib	Fostamatinib 100 mg tablet (batch 2)

Primary Outcome Measures

Name	Time	Method
Relative bioavailability of R406 when fostamatinib is administered as 50 mg tablets versus 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )	Daily during Treatment Period 4 until 96 hours post dose of each treatment period
Relative bioavailability of R406 when fostamatinib is administered as 3 different 100 mg tablet batches (assessment will include but is not limited to: plasma R406 AUC, Cmax )	Daily during Treatment Period 4 until 96 hours post dose of each treatment period

Secondary Outcome Measures

Name	Time	Method
To examine the safety and tolerability of fostamatinib 50 mg and 100 mg tablet batches The safety endpoints will include: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.	Screening, throughout the 4 treatment periods, and follow-up

Trial Locations

Locations (1)

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