Healthy Volunteers, Rheumatoid Arthritis
Conditions
Keywords
Phase 1, healthy volunteers, Rheumatoid arthritis, RA, Fostamatinib, Rifampicin, drug-drug interaction, Pharmacokinetics, Amount of Rifampicin in blood
Brief summary
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
Interventions
DRUGfostamatinib
oral tablets, 150mg (3 X 50mg) single dose per period
DRUGrifampicin
oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose | — |
| To examine the safety and tolerability of fostamatinib in combination with rifampicin. | From screening, Day 1 - Day 25, up to follow up visit | 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. |
Countries
United States
Outcome results
None listed