Effects of administration of fostamatinib on blood concentrations of an oral contraceptive in healthy female subjects
Study identifier:D4300C00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Scientific Terminology Rheumatoid arthritis, Healthy Female Volunteers, Pharmacokinetics, oral contraceptive, drug-drug interaction
Phase
Phase 1
Healthy volunteers
Yes
Study drug
fostamatinib, Microgynon® 30 (Oral contraceptive), Placebo
Sex
Female
Actual Enrollment
22
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Mar 2011
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 |
