Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis; Healthy Volunteers; Pharmacokinetics; Pioglitazone; Drug-drug Interaction; Amount of Pioglitazone in Blood
Intervention: fostamatinib (Drug); pioglitazone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Mark Layton, MD, MRCP, Study Director, Affiliation: AstraZeneca Carlos Prendes, MD, Principal Investigator, Affiliation: Quintiles Overland Park, Phase 1 Unit
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and CmaxTo assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Secondary outcome: To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and CmaxTo assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax To examine the safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
Starting date: March 2011
Last updated: July 6, 2011
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