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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309854
First Posted: March 7, 2011
Last Update Posted: July 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Healthy Volunteers Pharmacokinetics Pioglitazone Drug-drug Interaction Amount of Pioglitazone in Blood Drug: fostamatinib Drug: pioglitazone Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax [ Time Frame: Period 1: Pre-dose to 48h post dose ]
  • To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax [ Time Frame: 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 [ Time Frame: Period 1: Pre-dose to 48h post dose ]
  • To assess pharmacokinetics (PK) of hydroxypioglitazone (active metabolite) including but not limited to AUC and Cmax [ Time Frame: Period 2: Pre-dose to 48h post dose ]
  • To examine the safety and tolerability [ Time Frame: 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


Estimated Enrollment: 15
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309854


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Layton, MD, MRCP AstraZeneca
Principal Investigator: Carlos Prendes, MD Quintiles Overland Park, Phase 1 Unit
  More Information

Responsible Party: Mark Layton / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01309854     History of Changes
Other Study ID Numbers: D4300C00014
First Submitted: February 21, 2011
First Posted: March 7, 2011
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
pharmacokinetics
Rheumatoid arthritis
RA
fostamatinib
pioglitazone
drug-drug interaction

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs