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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01276262

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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 Drug: Microgynon® 30 (Oral contraceptive) Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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 Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Treatment A Monophasic oral contraceptive (Microgynon® 30) with placebo tablets	Drug: Microgynon® 30 (Oral contraceptive) Oral tablets, repeated doses Drug: Placebo Oral tablets BID, repeated doses for 21 days
Experimental: Treatment B Monophasic oral contraceptive (Microgynon® 30) and fostamatinib	Drug: fostamatinib Oral tablets, repeated doses for 21 days (2 x 50mg BID) Drug: Microgynon® 30 (Oral contraceptive) Oral tablets, repeated doses

Arm

Intervention/Treatment

Placebo Comparator: Treatment A

Monophasic oral contraceptive (Microgynon® 30) with placebo tablets

Drug: Microgynon® 30 (Oral contraceptive)

Oral tablets, repeated doses

Drug: Placebo

Oral tablets BID, repeated doses for 21 days

Experimental: Treatment B

Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Drug: fostamatinib

Oral tablets, repeated doses for 21 days (2 x 50mg BID)

Drug: Microgynon® 30 (Oral contraceptive)

Oral tablets, repeated doses

Outcome Measures

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 [From predose until Day 22 of each Treatment period]

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 [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 [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 [Screening, treatment periods 1 and 2, Follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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