Clinical trial NCT01276262: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
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
timeFrame: From predose until Day 22 of each Treatment period
Secondary outcomes:
measure: To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib
timeFrame: From predose until Day 22 of each Treatment period
measure: To determine R-406 plasma concentration-time profile and resulting PK parameters including AUCss, Cssmax, and tmaxss
timeFrame: From pre-dose until 12 hours following final dose on Day 21
measure: 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
timeFrame: Screening, treatment periods 1 and 2, Follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
References: