Expired Study
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Glendale, California


Purpose:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


Study is Available At:


Original ID:

D4300C00007


NCT ID:

NCT01167868


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase I, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Fostamatinib Disodium in Healthy Japanese and White Subjects After Single and Multiple Ascending Doses


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark Layton, MD
Study Director
AstraZeneca

Study Dates

Start Date:July 2010
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 6, 2013
First Received Date:July 19, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD.
Time Frame:Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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.
Time Frame:Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry.
Time Frame:Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:FosD
Description:oral tablet
Arm Name:FosD
Intervention Type:Drug
Name:Placebo
Description:oral tablet
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:FosD
Description: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
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo given (2 subjects in each cohort)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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