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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2011

Interventions

  • Drug: fostamatinib
    • Oral tablets, repeated doses for 21 days (2 x 50mg BID)
  • Drug: Microgynon® 30 (Oral contraceptive)
    • Oral tablets, repeated doses
  • Drug: Placebo
    • Oral tablets BID, repeated doses for 21 days

Arms, Groups and Cohorts

  • Placebo Comparator: Treatment A
    • Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
  • Experimental: Treatment B
    • Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor

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