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Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin

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 Atorvastatin; Healthy Volunteers

Intervention: Isavuconazole (Drug); atorvastatin (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 of a single dose of atorvastatin.

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 of Atorvastatin

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

Primary outcome: Pharmacokinetic (PK) profile for atorvastatin (in plasma):AUCinf, AUClast, Cmax

Secondary outcome:

PK profile for atorvaststin (in plasma): t1/2, tmax, CL/F, and Vz/F

PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax

PK Isavuconazole (in plasma): trough concentration (Ctrough)

Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject has a body weight of at least 45 kg and a body mass index of 18 to 32

kg/m2, inclusive

- The subject's clinical laboratory test results at Screening and Day 1 are within

normal limits unless the Investigator considers the abnormality to be "not clinically significant." Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must not be above the normal range

- Subject agrees to sexual abstinence, or is surgically sterile, or is using a

medically acceptable double barrier method to prevent pregnancy during the study and for three weeks after the follow up phone call at the end of the study, or, if female, is postmenopausal Exclusion Criteria:

- 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/had a symptomatic, viral, bacterial (including upper respiratory

infection), or fungal (non-cutaneous) infection within 1 week prior to clinic

admission on Day - 1.

- The subject has received a vaccination within the last 30 days prior to study drug

administration

- The subject has a positive result for hepatitis B surface antigen, hepatitis C

antibodies at Screening or is known to be positive for human immunodeficiency virus

- 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) in the

last 6 months

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

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

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,

or a positive drug screen at Screening or Day - 1

Locations and Contacts

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

Starting date: August 2012
Last updated: February 20, 2015

Page last updated: August 23, 2015

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