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

NCT01635946 | Completed Phase 1

• 1 other identifier: 9766-CL-0043
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics of Isavuconazole; Pharmacokinetics of Atorvastatin; Healthy Volunteers

Keywords

Isavuconazole; Atorvastatin; Healthy Volunteers; BAL8557; BAL4815; BAL8728

Outcome Measures

Primary Outcomes (1)

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

  Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax)

  Days 1 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose

Secondary Outcomes (4)

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

  Days 1 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose

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

  Days 11 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 20 hours post dose

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

  Predose on Day 10 and Days 13 through 14 and on Day 15 predose and 24 hours post dose

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

  Day 1 through Day 24 (± 2 days)

Study Arms (1)

Isavuconazole and atorvastatin

EXPERIMENTAL

Atorvastatin on Days 1 and 12, Isavuconazole three times per day (TID) on Days 8 and 9, and once daily (QD) on Days 10 thru 15

Drug: Isavuconazole; Drug: atorvastatin

Interventions

Isavuconazole DRUG

oral

Also known as: BAL8557

Isavuconazole and atorvastatin

atorvastatin DRUG

oral

Isavuconazole and atorvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Basilea Pharmaceutica International Ltd: collaborator

Study Sites (1)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

isavuconazole; Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

US (1)