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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01276262
First received: January 12, 2011
Last updated: February 17, 2012
Last verified: February 2012

January 12, 2011
February 17, 2012
March 2011
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276262 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction
  • Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction
  • 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
  • Placebo Comparator: Treatment A
    Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
    Interventions:
    • Drug: Microgynon® 30 (Oral contraceptive)
    • Drug: Placebo
  • Experimental: Treatment B
    Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
    Interventions:
    • Drug: fostamatinib
    • Drug: Microgynon® 30 (Oral contraceptive)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01276262
D4300C00012
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP