Study in Healthy Males to Assess Bioavailability of Single Fostamatinib With iv Micro Tracer Dose

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01598571
First received: April 5, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

Study in healthy males to assess bioavailability of single fostamatinib with iv micro tracer dose.


Condition Intervention Phase
Healthy
Drug: Fostamatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib With Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib. [ Time Frame: Up to 96 hours post dose ] [ Designated as safety issue: No ]
  • Total radioactivity of [14C] R406 after an intravenous infusion of [14C]R406 in terms of AUC, AUC(0-t), Cmax, t1/2λz, MRT, CL, Vz. [ Time Frame: Up to 96 hours post dose ] [ Designated as safety issue: No ]
    AUC-Area under the plasma concentration time curve; AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration; Cmax - max plasma concentration; t½ λz-Terminal half-life; MRT- Mean residence time; CL - Total body clearance; Vz - Volume of distribution during the terminal phase

  • Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406. [ Time Frame: 0, 30min, 1h, 1h 30min, 1h 45min, 1h 50min, 1h 55min, 2, 2h 5min, 2h 10min, 2h 15min, 2h30min, 3, 3h 30min, 5h30min, 9h, 12h, 18h, 24h, 30h, 48h, 72h, 96h post-dose ] [ Designated as safety issue: No ]
    PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT


Secondary Outcome Measures:
  • Number of participants with Adverse Events. [ Time Frame: Up to Day 12 ] [ Designated as safety issue: Yes ]
  • Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings. [ Time Frame: Up to Day 12 ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fostamatinib 50 mg tablet Drug: Fostamatinib
Fostamatinib 50 mg tablet
Experimental: Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose Drug: Fostamatinib
Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose

Detailed Description:

A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Fostamatinib with Respect to an Intravenous Micro Tracer Dose of [14C] R406 in Healthy Male Volunteers.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers aged 18 to 55 years (inclusive), with a weight of at least 50 kg and a body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
  • Male volunteers willing to use barrier contraception ie, condoms with spermicide, from the first day of the investigational product administration until 3 months after the last administration of the investigational product

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598571

Locations
United Kingdom
Ruddington, Nottingham, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD AstraZeneca, Alderley Park
Principal Investigator: Sharan Sidhu, MB CHB, BAO, MRCS Quotient Clinical Unit
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01598571     History of Changes
Other Study ID Numbers: D4300C00027, QBR112696
Study First Received: April 5, 2012
Last Updated: August 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
Healthy male volunteers
pharmacokinetics
fostamatinib
Bioavailability
R406 plasma AUC and Cmax
R406 plasma AUC0-t
t1/2λz
tmax

ClinicalTrials.gov processed this record on October 19, 2014