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

Pharmacokinetics Clinical Trial

Official title:

An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208155
• Other study ID #: D4300C00016
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2010
• Last updated: December 7, 2010
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability
• Pharmacokinetics

Intervention

Drug:
• Fostamatinib
Oral tablets, 50 mg x 2, single dose
• Fostamatinib
Oral tablets, 100 mg Batch 1, single dose
• Fostamatinib
Oral tablets, 100 mg Batch 2, single dose
• Fostamatinib
Oral tablets, 100 mg Batch 3, single dose

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 1 until 96 hours post dose of each treatment period	No
Primary	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 2 until 96 hours post dose of each treatment period	No
Primary	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 3 until 96 hours post dose of each treatment period	No
Primary	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	No
Primary	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 1 until 96 hours post dose of each treatment period	No
Primary	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 2 until 96 hours post dose of each treatment period	No
Primary	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 3 until 96 hours post dose of each treatment period	No
Primary	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	No
Secondary	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	Yes