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

NCT ID: NCT01597986

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Keywords

isavuconazole; ethinyl estradiol; norethindrone; contraceptive; Healthy Volunteers; BAL8557; BAL4815

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Isavuconazole and oral contraceptive

Arm description(as needed): Subjects receive single dose of oral contraceptive consisting of ethinyl estradiol and norethindrone on Days 1 and 13 and oral doses of isavuconazole every 8 hours on Days 9 and 10 followed by a once a day dose in the mornings on Days 11 through 16.

Group Type: EXPERIMENTAL

isavuconazole

Intervention Type: DRUG

oral

Oral Contraceptive (ethinyl estradiol / norethindrone)

Intervention Type: DRUG

contraceptive pill consisting of ethinyl estradiol and norethindrone

Interventions

isavuconazole

oral

Intervention Type: DRUG

Oral Contraceptive (ethinyl estradiol / norethindrone)

contraceptive pill consisting of ethinyl estradiol and norethindrone

Intervention Type: DRUG

Other Intervention Names

BAL8557; BAL4815; Ortho-Novum

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Basilea Pharmaceutica International Ltd

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Clinical Pharmacology of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

9766-CL-0031

Identifier Type: -

Identifier Source: org_study_id