Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects

Phase 1

Completed

• Conditions: Rheumatoid Arthritis; Healthy Volunteers; Pharmacokinetics; Pioglitazone; Drug-drug Interaction; Amount of Pioglitazone in Blood
• Interventions: Drug: fostamatinib; Drug: pioglitazone

• Registration Number: NCT01309854
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-21
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-06
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pioglitazone	fostamatinib	-
pioglitazone	pioglitazone	-
pioglitazone and fostamatinib	pioglitazone	-

Primary Outcome Measures

Name	Time	Method
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax	Period 2: Pre-dose to 48h post dose

Secondary Outcome Measures

Name	Time	Method
To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax	Period 2: 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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States