NCT01387308

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

June 30, 2011

Last Update Submit

October 27, 2011

Conditions

Healthy

Keywords

Phase 1Healthy male volunteerspharmacokineticsfostamatinibScientific Terminology: Bioavailability, R406 plasma AUC and C_maxR406 plasma AUC0-t, t1/2λz and t_maxLaymen Terminology: Amount of R406 in blood

Outcome Measures

Primary Outcomes (2)

  • To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 100-mg tablet versus 2 x 50-mg tablets (Phase III formulation)

    Assessments will include but is not limited to: plasma R406 AUC, Cmax

    From Pre-dose until 96 hours post dose of each treatment period

  • To assess the relative bioavailability of R406 in healthy volunteers when fostamatinib is administered as a reformulated 150-mg tablet versus 3 x 50-mg tablets (Phase III formulation)

    Assessments will include but is not limited to: plasma R406 AUC, Cmax )

    From pre-dose until 96 hours post dose of each treatment period

Secondary Outcomes (2)

  • To examine the safety and tolerability of fostamatinib 50 mg, 100 mg, and 150 mg tablet batches

    From pre-dose until 96 hours post dose of each treatment period

  • To estimate the within subject variability in R406 exposure when fostamatinib 50 mg tablets are administered on 2 separate occasions.

    From pre-dose until 96 hours post dose of each treatment period

Study Arms (5)

A

EXPERIMENTAL

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Drug: Fostamatinib

B

SHAM COMPARATOR

Fostamatinib 50 mg tablet x 3 (Phase 3 batch)

Drug: Fostamatinib

C

EXPERIMENTAL

Fostamatinib 100 mg tablet (new formulation)

Drug: Fostamatinib

D

EXPERIMENTAL

Fostamatinib 150 mg tablet (new formulation)

Drug: Fostamatinib

E

EXPERIMENTAL

Fostamatinib 50 mg tablet x 2 (Phase 3 batch)

Drug: Fostamatinib

Interventions

FostamatinibDRUG

Oral tablets, 50 mg x 2, single dose

A

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed and dated informed consent prior to any study specific procedures
  • Volunteers will be males aged 18 to 55 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Volunteers agreeing to participate in the optional genetic research must provide a separate, signed, written and dated informed consent for genetic research. The volunteer will not be excluded from other aspects of the study described in this Clinical Study Protocol so long as they consent to them

You may not qualify if:

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
  • Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

fostamatinib

Study Design

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

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 4, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

US(1)