Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Primary Purpose
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
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
fostamatinib
Microgynon® 30 (Oral contraceptive)
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction focused on measuring Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Treatment A
Treatment B
Arm Description
Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
Outcomes
Primary Outcome 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
Secondary Outcome 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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01276262
Brief Title
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Placebo Comparator
Arm Description
Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
Oral tablets, repeated doses for 21 days (2 x 50mg BID)
Intervention Type
Drug
Intervention Name(s)
Microgynon® 30 (Oral contraceptive)
Intervention Description
Oral tablets, repeated doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets BID, repeated doses for 21 days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib
Description
PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin
Time Frame
From predose until Day 22 of each Treatment period
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
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