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Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

NCT01682408 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-12-28

No results posted yet for this study

Summary

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Conditions

  • Pharmacokinetics

Interventions

DRUG

Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)

DRUG

Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

DRUG

Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)

DRUG

Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)

1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)

DRUG

Ranitidine

150 mg ranitidine

Sponsors & Collaborators

Principal Investigators

  • Eleanor Lisbon, MD · Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211

  • Christopher D O'Brien, MD PHD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01682408 on ClinicalTrials.gov