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

AstraZeneca

Status and phase: Completed; Phase 1

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

Treatments: Drug: Placebo; Drug: Microgynon® 30 (Oral contraceptive); Drug: fostamatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01276262

D4300C00012

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Description:

Monophasic oral contraceptive (Microgynon® 30) with placebo tablets

Treatment:

Drug: Placebo

Drug: Microgynon® 30 (Oral contraceptive)

Treatment B

Experimental group

Description:

Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Treatment:

Drug: fostamatinib

Drug: Microgynon® 30 (Oral contraceptive)