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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 Cmax

To 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 Cmax

To 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

Page last updated: August 20, 2015

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