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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01309854
First received: February 21, 2011
Last updated: July 6, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax [ Time Frame: Period 2: Pre-dose to 48h post dose ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To examine the safety and tolerability [ Time Frame: From screening, Day -1 to Day 9 and follow up visit (Day 16) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Layton / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01309854     History of Changes
Other Study ID Numbers: D4300C00014
Study First Received: February 21, 2011
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013