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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Ranitidine; Drug: Fostamatinib - 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 A); Drug: Fostamatinib - 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682408

D4300C00019

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

• 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)

Trial design

28 participants in 5 patient groups

Part A1

Active Comparator group

Description:

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

Treatment:

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

Part A2

Active Comparator group

Description:

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

Treatment:

Drug: 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

Part B1

Active Comparator group

Description:

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

Treatment:

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

Part B2

Active Comparator group

Description:

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

Treatment:

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

Part B3

Active Comparator group

Description:

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

Treatment:

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