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

Primary Purpose

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

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

fostamatinib

Microgynon® 30 (Oral contraceptive)

Placebo

About this trial

This is an interventional basic science trial for Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction focused on measuring Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Treatment A

Treatment B

Arm Description

Monophasic oral contraceptive (Microgynon® 30) with placebo tablets

Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Outcomes

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

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

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

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

Full Information

NCT ID

NCT01276262

First Posted

January 12, 2011

Last Updated

February 17, 2012

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01276262

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Phase 1, healthy female volunteers, oral contraceptive, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Placebo Comparator

Arm Description

Monophasic oral contraceptive (Microgynon® 30) with placebo tablets

Arm Title

Treatment B

Arm Type

Experimental

Arm Description

Monophasic oral contraceptive (Microgynon® 30) and fostamatinib

Intervention Type

Drug

Intervention Name(s)

fostamatinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Microgynon® 30 (Oral contraceptive)

Intervention Description

Oral tablets, repeated doses

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablets BID, repeated doses for 21 days

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib

Description

PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin

Time Frame

From predose until Day 22 of each Treatment period

Title

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

Title

Time Frame

Screening, treatment periods 1 and 2, Follow up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Research Site

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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