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

NCT01208155 | Completed Phase 1

• 1 other identifier: D4300C00016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioavailability; Pharmacokinetics

Keywords

Phase 1; Healthy; pharmacokinetics; Fostamatinib

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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 1 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 2 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 3 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 Outcomes (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

Study Arms (4)

1

EXPERIMENTAL

Fostamatinib 50 mg tablet x 2

Drug: Fostamatinib

2

EXPERIMENTAL

Fostamatinib 100 mg tablet (batch 1)

Drug: Fostamatinib

3

EXPERIMENTAL

Fostamatinib 100 mg tablet (batch 2)

Drug: Fostamatinib

4

EXPERIMENTAL

Fostamatinib 100 mg tablet (batch 4)

Drug: Fostamatinib

Interventions

Fostamatinib DRUG

Oral tablets, 50 mg x 2, single dose

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

fostamatinib

Study Officials

• Mark Layton, MD

  AstraZeneca

  STUDY DIRECTOR

• Carlos Prendes, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 23, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

US (1)