A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects

NCT01167868 | Completed Phase 1

• 1 other identifier: D4300C00007
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry.

  Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days

Secondary Outcomes (2)

• To determine plasma PK parameters (including but not limited to: AUC, tmax, Cmax, terminal elimination half life (t1/2) and accumulation ratio (Rac)) of FosD.

  Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing.

• To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD.

  Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing.

Study Arms (2)

FosD

EXPERIMENTAL

Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects

Drug: FosD

Placebo

PLACEBO COMPARATOR

Placebo given (2 subjects in each cohort)

Drug: Placebo

Interventions

FosD DRUG

oral tablet

FosD

Placebo DRUG

oral tablet

Placebo

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 and White subjects (origins in Europe, the Middle East, or North Africa)
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, United States

Location

Study Officials

• Mark Layton, MD

  AstraZeneca

  STUDY DIRECTOR

• Mark Yen, MD

  PAREXEL Early Phase/California Clinical Trials Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

US (1)