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CompletedNCT01682408PK CombinationUpdated Dec 28, 2012

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

A Phase 1 interventional study of Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) and Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed in Pharmacokinetics, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-28.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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

Read the detailed description

An Open-label, Single-center, 2-Part, Randomized 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

02

Conditions studied

  • Pharmacokinetics

Keywords

  • R406,
  • Fostamatinib,
  • Phase I,
  • Healthy Subjects,
  • Pharmacokinetics,
  • Fed/Fasted
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling and analyses
  • Volunteers will be males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive.
  • Provision of signed, written, and dated informed consent for optional genetic research. If a volunteer declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the volunteer.
  • Male volunteers should be willing to use barrier contraception, ie, condoms from the day of first dosing until 2 weeks after dosing with the IP in Treatment Period 5.
  • Females must have a negative pregnancy test at screening and on admission to the CPU (including check-in at each treatment period), must not be lactating and must be of non childbearing potential, confirmed at screening

Exclusion criteria

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
  • 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 IP
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Part A1

    1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed

    Drug: Fostamatinib - 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

  • Active comparator
    Part A2

    1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine

    Drug: Fostamatinib - 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 · Drug: Ranitidine

  • Active comparator
    Part B1

    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 A)

  • Active comparator
    Part B2

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

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

  • Active comparator
    Part B3

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

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

Interventions

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

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

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

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

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

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

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

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

  • DrugRanitidine

    150 mg ranitidine

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics profile of R406 in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).

    Time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

Secondary outcomes

  1. Pharmacokinetic profile of R406 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)], time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz).

    Time frame: Day 1 (predose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose

  2. Description of the safety profile in terms of frequency of adverse events.

    Time frame: up to 3 - 5 days after discharge

  3. Description of the safety profile in terms of severity of adverse events.

    Time frame: up to 3 - 5 days after discharge

07

Study locations

1 site
  • Overland Park, Kansas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01682408
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 10, 2012
Start date
Sep 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 28, 2012

Study contacts

Eleanor Lisbon, MD
principal investigator · Quintiles Phase I unit 6700 w 115th st Overland Park, Ks 66211
Christopher D O'Brien, MD PHD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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