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Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Intervention: isavuconazole (Drug); Oral Contraceptive (ethinyl estradiol / norethindrone) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Astellas Pharma Global Development, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Global Development

Summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.

Clinical Details

Official title: A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax

Secondary outcome:

PK variable for ethinyl estradiol and norethindrone (in plasma): tmax , t1/2 , Vz /F, and CL/F

PK variable for isavuconazole (in plasma): Ctrough

PK variable for isavuconazole (in plasma): AUCtau, Cmax, and tmax

Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs)

Eligibility

Minimum age: 50 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18

to 32 kg/m2, inclusive

- Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and

total bilirubim must not be above upper limit of normal range

- The subject must be postmenopausal, defined as at least 2 years since the last

regular menstrual cycle and have follicle stimulating hormone (FSH) > 30 IU/L Exclusion Criteria:

- The subject has had treatment with hormone replacement therapy within 3 months prior

to Day - 1

- The subject has a history of adverse events with taking oral contraceptives or

hormone replacement therapy

- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac

arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)

- The subject has a positive result for hepatitis C antibodies or hepatitis B surface

antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)

- The subject has a known or suspected allergy to any of the components of the trial

products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions

- The subject is a smoker (any use of tobacco or nicotine containing products) within 6

months prior to Screening

- The subject has had treatment with prescription drugs or complementary and

alternative medicines within 14 days prior to Day - 1, or over-the-counter medications

within 1 week prior to Day - 1, with the exception of acetaminophen up to 2 g/day

- The subject has a recent history (within the last 2 years) of drug or alcohol abuse,

as defined by the investigator, or a positive drug and/or alcohol screen

Locations and Contacts

Clinical Pharmacology of Miami, Miami, Florida 33014, United States
Additional Information

Starting date: April 2012
Last updated: July 12, 2012

Page last updated: August 23, 2015

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