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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01276262
First received: January 12, 2011
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
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
 Drug: fostamatinib
Drug: Microgynon® 30 (Oral contraceptive)
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the effects of repeated doses of Fostamatinib on the pharmacokinetics of Microgynon ®30 by assessment of Cssmax and AUCss of ethinyl estradiol (EE), levonorgestrel on Day 21 [ Time Frame: From predose until Day 22 of each Treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib [ Time Frame: From predose until Day 22 of each Treatment period ] [ Designated as safety issue: No ]
    PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin

  • To determine R-406 plasma concentration-time profile and resulting PK parameters including AUCss, Cssmax, and tmaxss [ Time Frame: From pre-dose until 12 hours following final dose on Day 21 ] [ Designated as safety issue: No ]
  • To determine the safety and tolerability of fostamatinib in combination with an oral contraceptive (Microgynon ®30): adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs [ Time Frame: Screening, treatment periods 1 and 2, Follow up ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276262

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01276262     History of Changes
Other Study ID Numbers: D4300C00012
Study First Received: January 12, 2011
Last Updated: February 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Contraceptive Agents
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
 Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on May 22, 2013