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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01208155
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bioavailability; Pharmacokinetics	Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib; Drug: Fostamatinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open-label, Randomized, Four-way Crossover Study in Healthy Male Subjects to Assess the Relative Bioavailability of 4 Different Fostamatinib Tablets
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Fostamatinib 50 mg tablet x 2	Drug: Fostamatinib; Oral tablets, 50 mg x 2, single dose
Experimental: 2 Fostamatinib 100 mg tablet (batch 1)	Drug: Fostamatinib; Oral tablets, 100 mg Batch 1, single dose
Experimental: 3 Fostamatinib 100 mg tablet (batch 2)	Drug: Fostamatinib; Oral tablets, 100 mg Batch 2, single dose
Experimental: 4 Fostamatinib 100 mg tablet (batch 4)	Drug: Fostamatinib; Oral tablets, 100 mg Batch 3, single dose

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

8. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Mark Layton, MD, AstraZeneca
• Principal Investigator: Carlos Prendes, MD, Quintiles, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01208155
• Other Study ID Numbers: D4300C00016
• First Posted: Sep 23, 2010
• Last Update Posted: Dec 8, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Phase 1; Healthy; pharmacokinetics; Fostamatinib

Study Results

No Results Posted as of Dec 8, 2010