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

NCT01276262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-02-20

No results posted yet for this study

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

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

Interventions

DRUG

fostamatinib

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

DRUG

Microgynon® 30 (Oral contraceptive)

Oral tablets, repeated doses

DRUG

Placebo

Oral tablets BID, repeated doses for 21 days

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276262 on ClinicalTrials.gov