ClinicalTrials.Veeva

Menu

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

AstraZeneca logo

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

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems