Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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
Intervention: fostamatinib (Drug); Microgynon® 30 (Oral contraceptive) (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca
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
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Primary outcome: 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: To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinibTo 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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
Research Site, London, United Kingdom
Additional Information
Starting date: March 2011
Last updated: February 17, 2012
|