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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01309854

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Healthy Volunteers Pharmacokinetics Pioglitazone Drug-drug Interaction Amount of Pioglitazone in Blood	Drug: fostamatinib Drug: pioglitazone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Mar 1, 2011

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pioglitazone	Drug: fostamatinib oral tablets, 100mg (2 X 50mg) twice daily for 8 days Drug: pioglitazone oral tablets, 30mg single dose per period
Experimental: pioglitazone and fostamatinib	Drug: pioglitazone oral tablets, 30mg single dose per period

Arm

Intervention/Treatment

Experimental: pioglitazone

Drug: fostamatinib

oral tablets, 100mg (2 X 50mg) twice daily for 8 days

Drug: pioglitazone

oral tablets, 30mg single dose per period

Experimental: pioglitazone and fostamatinib

Drug: pioglitazone

oral tablets, 30mg single dose per period

Outcome Measures

Primary Outcome Measures

To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax [Period 1: Pre-dose to 48h post dose]
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

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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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