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

Pharmacokinetics Clinical Trial

— PK Combination  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682408
• Other study ID #: D4300C00019
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2012
• Last updated: December 27, 2012
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		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	No
Secondary	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 (t1/2?z), terminal rate constant (?z).		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	No
Secondary	Description of the safety profile in terms of frequency of adverse events.		up to 3 - 5 days after discharge	Yes
Secondary	Description of the safety profile in terms of severity of adverse events.		up to 3 - 5 days after discharge	Yes