A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese Subjects

NCT01608542 | Completed Phase 1

• 1 other identifier: D4300C00032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single and multiple dose study in healthy male and female (of non-child bearing potential) Japanese volunteers, to assess the blood and urine drug levels of Fostamatinib. Fostamatinib is being developed for the treatment of rheumatoid arthritis.

Conditions

Healthy Japanese Volunteers

Keywords

fostamatinib; FosD; Japanese Healthy volunteers; Phase 1; Single and Multiple Dose Study

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) profile of fostamatinib from blood and urine in terms of AUC; tmax; Cmax; t1/2 and Rac.

  AUC - area under the plasma concentration time curve from zero to infinity ; tmax - time to max plasma concentration; t1/2 - terminal elimination half life; Rac - accumulation ratio

  PK sampling at predose, 0, 0.25, 0.5, 1,1.5, 2, 4, 6, 8,12, 16, 24, 36, 48 and 72 hours post-dose following the single dose (on Day 1) and after repeated twice daily dosing on Days 4 and 10

Secondary Outcomes (1)

• Safety and tolerability profile in terms of adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG

  Up to Day 20

Study Arms (2)

Fostamatinib 100mg

EXPERIMENTAL

Up to two cohorts of Japanese subjects are planned to receive fostamatinib 100mg single and multiple twice daily doses

Drug: Fostamatinib 100mg

Fostamatinib 200mg

EXPERIMENTAL

Up to two cohorts of Japanese subjects are planned to receive fostamatinib 200mg single and multiple twice daily doses

Drug: Fostamatinib 200mg

Interventions

Fostamatinib 100mg DRUG

oral tablet

Fostamatinib 100mg

Fostamatinib 200mg DRUG

oral tablet

Fostamatinib 200mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female (of non-childbearing potential) Japanese subjects
• to 45 years of age
• Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg

You may not qualify if:

• History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
• Any clinically significant illness, acute infection, known inflammatory process, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
• Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
• Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
• Previous participation in a fostamatinib study

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

MeSH Terms

Interventions

fostamatinib

Study Officials

• Mark Layton, MD

  AstraZeneca

  STUDY DIRECTOR

• David Han, MD

  PAREXEL Early Phase/California Clinical Trials Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: May 31, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

US (2)