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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309854
• Other study ID #: D4300C00014
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2011
• Last updated: July 6, 2011
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Amount of Pioglitazone in Blood
• Arthritis, Rheumatoid
• Drug-drug Interaction
• Healthy Volunteers
• Pharmacokinetics
• Pioglitazone
• Rheumatoid Arthritis

Intervention

Drug:
• fostamatinib
oral tablets, 100mg (2 X 50mg) twice daily for 8 days
• pioglitazone
oral tablets, 30mg single dose per period

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax		Period 1: Pre-dose to 48h post dose	No
Primary	To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax		Period 2: Pre-dose to 48h post dose	No
Secondary	To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax		Period 1: Pre-dose to 48h post dose	No
Secondary	To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax		Period 2: Pre-dose to 48h post dose	No
Secondary	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	From screening, Day -1 to Day 9 and follow up visit (Day 16)	Yes