Back to resultsEffects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
Primary Purpose
Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fostamatinib
pioglitazone
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pioglitazone
pioglitazone and fostamatinib
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01309854
Brief Title
Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Healthy Volunteers, Pharmacokinetics, Pioglitazone, Drug-drug Interaction, Amount of Pioglitazone in Blood
Keywords
Phase 1, healthy volunteers, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, pioglitazone, drug-drug interaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pioglitazone
Arm Type
Experimental
Arm Title
pioglitazone and fostamatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
oral tablets, 100mg (2 X 50mg) twice daily for 8 days
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Description
oral tablets, 30mg single dose per period
Primary Outcome Measure Information:
Title
To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax
Time Frame
Period 1: Pre-dose to 48h post dose
Title
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 Measure Information:
Title
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
Title
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
Title
To examine the safety and tolerability
Description
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
Time Frame
From screening, Day -1 to Day 9 and follow up visit (Day 16)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Layton, MD, MRCP
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Prendes, MD
Organizational Affiliation
Quintiles Overland Park, Phase 1 Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects
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