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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
oral tablets, 100mg (2 X 50mg) twice daily for 8 days
oral tablets, 30mg single dose per period
Research Site
Overland Park, Kansas, United States
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Time frame: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Time frame: Period 2: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Time frame: Period 1: Pre-dose to 48h post dose
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
Time frame: Period 2: Pre-dose to 48h post dose
To examine the safety and tolerability
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
Time frame: From screening, Day -1 to Day 9 and follow up visit (Day 16)
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