Skip to main content
OpenTrials
Completed

NCT Number: NCT01309854

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Amount of Pioglitazone in Blood Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Drug-drug Interaction Healthy Volunteers Immune System Diseases Joint Diseases Musculoskeletal Diseases Pharmacokinetics Pioglitazone Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fostamatinib

Drug

oral tablets, 100mg (2 X 50mg) twice daily for 8 days

pioglitazone

Drug

oral tablets, 30mg single dose per period

Primary outcomes

  1. To assess pharmacokinetics (PK) of pioglitazone including but not limited to AUC and Cmax

    Time frame: Period 1: Pre-dose to 48h post dose

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 7, 2011
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.