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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment A

Monophasic oral contraceptive (Microgynon® 30) with placebo tablets

Group Type PLACEBO_COMPARATOR

Microgynon® 30 (Oral contraceptive)

Intervention Type DRUG

Oral tablets, repeated doses

Placebo

Intervention Type DRUG

Oral tablets BID, repeated doses for 21 days

Treatment B

Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Group Type EXPERIMENTAL

fostamatinib

Intervention Type DRUG

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

Microgynon® 30 (Oral contraceptive)

Intervention Type DRUG

Oral tablets, repeated doses

Interventions

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fostamatinib

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

Intervention Type DRUG

Microgynon® 30 (Oral contraceptive)

Oral tablets, repeated doses

Intervention Type DRUG

Placebo

Oral tablets BID, repeated doses for 21 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes