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Completed

NCT Number: NCT01336218

Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

The purpose of this study is to investigate the drug interaction between fostamatinib and rifampicin by comparing the safety, tolerability and plasma concentration of fostamatinib when administered alone and with rifampicin in healthy subjects

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Healthy Volunteers Immune System Diseases Joint Diseases Musculoskeletal Diseases 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 aged 18 to 55 years (inclusive)
  • Minimum weight of 50 kg and a body mass index (BMI) of 18 to 35 kg/m2 (inclusive)
  • Female subjects must have a negative pregnancy test at screening and admission of each treatment period, must not be lactating, and must be of non-childbearing potential

Exclusion criteria

  • History or presence of gastrointestinal, hepatic or renal disease (except for cholecystectomy)
  • Any clinically significant illness, medical or surgical procedure, or trauma within 4 weeks before Period 1 Day 1
  • 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

Treatment and study plan

Fostamatinib

Drug

oral tablets, 150mg (3 X 50mg) single dose per period

rifampicin

Drug

oral tablets, 600mg (2 X 300mg) 8 doses over 8 days

Primary outcomes

  1. To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC and Cmax will be measured

    Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose

Secondary outcomes

  1. To assess the pharmacokinetics of R406 in healthy subjects when a single dose of fostamatinib is administered alone and in combination with rifampicin. AUC (0-t), terminal half life, and tmax will be measured

    Time frame: Period 1: Day 1 to 96 hours post-dose Period 2: Day 6 to 96 hours post-dose

  2. To examine the safety and tolerability of fostamatinib in combination with rifampicin.

    Time frame: From screening, Day 1 - Day 25, up to follow up visit

    Assessments include: Adverse events, laboratory assessments, vital signs, physical examination and 12-lead electrocardiogram. Absolute values and change in baseline for any of these parameters will be reported.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2011
Registry last updated
Jul 22, 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.

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