Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects. - Full Text View

Purpose

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects

Condition	Intervention	Phase
Rheumatoid Arthritis Healthy Volunteers	Drug: fostamatinib Drug: rifampicin	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Resource links provided by NLM:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis

Drug Information available for: Rifampin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured [ Time Frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose ] [ Designated as safety issue: No ]
To examine the safety and tolerability of fostamatinib in combination with rifampicin. [ Time Frame: From screening, Day 1 - Day 25, up to follow up visit ] [ Designated as safety issue: Yes ]
Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.


Estimated Enrollment:	15
Study Start Date:	April 2011
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fostamatinib	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period
Experimental: 2 Rifampicin	Drug: fostamatinib oral tablets, 150mg (3 X 50mg) single dose per period Drug: rifampicin oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Males or females aged 18 to 55 years (inclusive)
Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
Any previous treatment with fostamatinib

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336218

Locations


United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

More Information


Responsible Party:	Kelli Craven, MD, PI, Quintiles, Overland Park, volunteer recruitment
ClinicalTrials.gov Identifier:	NCT01336218 History of Changes
Other Study ID Numbers:	D4300C00015
Study First Received:	April 14, 2011
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


Phase 1 healthy volunteers Rheumatoid arthritis RA Fostamatinib	Rifampicin drug-drug interaction Pharmacokinetics Amount of Rifampicin in blood

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Rifampin Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents	Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on September 27, 2016