Clinical trial NCT01309854: Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
Official title: An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Healthy Volunteers
Pharmacokinetics
Pioglitazone
Drug-drug Interaction
Amount of Pioglitazone in Blood
Keywords: Phase 1
healthy volunteers
pharmacokinetics
Rheumatoid arthritis
RA
fostamatinib
pioglitazone
drug-drug interaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
timeFrame: Period 1: Pre-dose to 48h post dose
measure: To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
timeFrame: Period 2: Pre-dose to 48h post dose
Secondary outcomes:
measure: To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
timeFrame: Period 1: Pre-dose to 48h post dose
measure: To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax
timeFrame: Period 2: Pre-dose to 48h post dose
measure: To examine the safety and tolerability
timeFrame: From screening, Day -1 to Day 9 and follow up visit (Day 16)
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Mark Layton, MD, MRCP
role: STUDY_DIRECTOR
affiliation: Quintiles Overland Park, Phase 1 Unit
name: Carlos Prendes, MD
role: PRINCIPAL_INVESTIGATOR
References: