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NCT Number: NCT01276262

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

A crossover study to assess the effect of repeated doses of fostamatinib on the levels of oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib. The study will also evaluate the safety and tolerability of fostamatinib in combination with an oral contraceptive

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Key information

Conditions

Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects of age 18 to 45 years, inclusive, who are healthy, non-pregnant, not planning pregnancy within the study period
  • Willing to use a highly effective method of birth control, ie, double barrier method contraception (condom and diaphragm with spermicide) from the first day of Period 1 until 28 days after the last dose
  • Body weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Two negative pregnancy tests at least 7 days apart

Exclusion criteria

  • History of any clinically significant disease or disorder
  • History or presence of Gastrointestinal, hepatic, or renal disease
  • Any condition listed as a contraindication in the Microgynon® 30 labelling
  • Absolute neutrophil count less than 2.5 x 109/L.

Treatment and study plan

Fostamatinib

Drug

Oral tablets, repeated doses for 21 days (2 x 50mg BID)

Microgynon® 30 (Oral contraceptive)

Drug

Oral tablets, repeated doses

Placebo

Drug

Oral tablets BID, repeated doses for 21 days

Primary outcomes

  1. To assess the effects of repeated doses of Fostamatinib on the pharmacokinetics of Microgynon ®30 by assessment of Cssmax and AUCss of ethinyl estradiol (EE), levonorgestrel on Day 21

    Time frame: From predose until Day 22 of each Treatment period

Secondary outcomes

  1. To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib

    Time frame: From predose until Day 22 of each Treatment period

    PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin

  2. To determine R-406 plasma concentration-time profile and resulting PK parameters including AUCss, Cssmax, and tmaxss

    Time frame: From pre-dose until 12 hours following final dose on Day 21

  3. To determine the safety and tolerability of fostamatinib in combination with an oral contraceptive (Microgynon ®30): adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs

    Time frame: Screening, treatment periods 1 and 2, Follow up

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2011
Registry last updated
Feb 20, 2012

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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