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

NCT01598571 | Completed Phase 1

• 2 other identifiers: D4300C00027QBR112696
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Phase 1; Healthy male volunteers; pharmacokinetics; fostamatinib; Bioavailability; R406 plasma AUC and Cmax; R406 plasma AUC0-t; t1/2λz; tmax

Outcome Measures

Primary Outcomes (3)

• The percent of absolute bioavailability (F) of R406 after oral administration of fostamatinib.

  Up to 96 hours post dose

• 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.

  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

  Up to 96 hours post dose

• Pharmacokinetic (PK) profile of a single oral dose of fostamatinib and a radiolabelled intravenous micro tracer dose of [14C] R406.

  PK Parameters: AUC, AUC (0-t), Cmax, t½ λz and MRT

  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

Secondary Outcomes (2)

• Number of participants with Adverse Events.

  Up to Day 12

• Safety profile in terms of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs and physical examination findings.

  Up to Day 12

Study Arms (2)

Fostamatinib 50 mg tablet

EXPERIMENTAL

Drug: Fostamatinib

Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose

EXPERIMENTAL

Drug: Fostamatinib

Interventions

Fostamatinib DRUG

Fostamatinib 50 mg tablet

Fostamatinib 50 mg tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Unknown Facility

Ruddington, Nottingham, United Kingdom

Location

MeSH Terms

Interventions

fostamatinib

Study Officials

• Mark Layton, MD

  AstraZeneca, Alderley Park

  STUDY DIRECTOR

• Sharan Sidhu, MB CHB, BAO, MRCS

  Quotient Clinical Unit

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

GB (1)