Amount of Pioglitazone in Blood, Drug-drug Interaction, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Rheumatoid Arthritis
Conditions
Keywords
Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction
Brief summary
The purpose of this study is to investigate the drug interaction between fostamatinib and pioglitazone by comparing the safety, tolerability and plasma concentration of pioglitazone when administered alone and with fostamatinib in healthy subjects.
Interventions
DRUGfostamatinib
oral tablets, 100mg (2 X 50mg) twice daily for 8 days
DRUGpioglitazone
oral tablets, 30mg single dose per period
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 (of non-child bearing potential) aged 18 to 55 years (inclusive) * Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive) * Males must be willing to use barrier contraception ie, condoms, from the first administration until 2 weeks after the last administration of the investigational product
Exclusion criteria
* History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy) * Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product * 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 or pioglitazone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax | Period 1: Pre-dose to 48h post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax | Period 1: Pre-dose to 48h post dose | — |
| To examine the safety and tolerability | From screening, Day -1 to Day 9 and follow up visit (Day 16) | To examine the safety and tolerability of fostamatinib in combination with pioglitazone. Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram |
Countries
United States
Outcome results
None listed