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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Fostamatinib 50 mg tablet x 2 (Phase 3 batch)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 50 mg x 3, single dose; Drug: Fostamatinib; Oral tablets, 100 mg, single dose; Drug: Fostamatinib; Oral tablets, 150 mg, single dose
Sham Comparator: B; Fostamatinib 50 mg tablet x 3 (Phase 3 batch)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 50 mg x 3, single dose; Drug: Fostamatinib; Oral tablets, 100 mg, single dose; Drug: Fostamatinib; Oral tablets, 150 mg, single dose
Experimental: C; Fostamatinib 100 mg tablet (new formulation)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 50 mg x 3, single dose; Drug: Fostamatinib; Oral tablets, 100 mg, single dose; Drug: Fostamatinib; Oral tablets, 150 mg, single dose
Experimental: D; Fostamatinib 150 mg tablet (new formulation)	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose; Drug: Fostamatinib; Oral tablets, 50 mg x 3, single dose; Drug: Fostamatinib; Oral tablets, 100 mg, single dose; 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; Drug: Fostamatinib; Oral tablets, 50 mg x 3, single dose; Drug: Fostamatinib; Oral tablets, 100 mg, single dose; Drug: Fostamatinib; Oral tablets, 150 mg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Assessments will include but is not limited to: plasma R406 AUC, Cmax	From Pre-dose until 96 hours post dose of each treatment period
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)	Assessments will include but is not limited to: plasma R406 AUC, Cmax )	From pre-dose until 96 hours post dose of each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches	The safety endpoints will include adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.	From pre-dose until 96 hours post dose of each treatment period
To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.	Assessments will include but is not limited to: plasma R406 plasma AUC0-t, t1/2, and tmax	From pre-dose until 96 hours post dose of each treatment period

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 27, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; Phase 1; Healthy male volunteers; 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
• Other Study ID Numbers: D4300C00018