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Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

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 Lopinavir/Ritonavir; Healthy Volunteers

Intervention: Isavuconazole (Drug); Lopinavir/ritonavir (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 two part study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole. Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir on isavuconazole. Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone, lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.

Clinical Details

Official title: A Phase 1, Open-Label, Parallel Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Multiple Doses of Lopinavir/Ritonavir and the Effects of Lopinavir/Ritonavir on the Pharmacokinetics of Multiple Doses of Isavuconazole in Healthy Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Pharmacokinetic (PK) for isavuconazole: AUCtau

Pharmacokinetic (PK) profile for isavuconazole: AUC tau and Cmax

Pharmacokinetic (PK) profile for lopinavir/ritonavir: AUC tau and Cmax

Secondary outcome:

PK for isavuconazole (in plasma): trough concentration (Ctrough)

PK profile for isavuconazole (in plasma): Cmax, tmax

PK for lopinavir/ritonavir (in plasma): trough concentration (Ctrough)

PK for lopinavir/ritonavir (in plasma): tmax

Safety and tolerability of isavuconazole alone and in combination with lopinavir (LPV) and ritonavir (RTV) assessed by recording of adverse events, physical examination, 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 has a body mass index (BMI) of 18

to 32 kg/m2, inclusive

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

total bilirubin, lipase, amylase, glucose and triglycerides must be within the normal range

- The female subject agrees to sexual abstinence, or is surgically sterile,

postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e. g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening

and Day - 1

- The male subject agrees to sexual abstinence, is surgically sterile, or is using a

medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study 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 a history of pancreatitis

- The subject has a positive result for hepatitis C antibodies, 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 including lopinavir/ritonavir 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

- The subject has participated in a previous isavuconazole study

Locations and Contacts

Parexel International, Glendale, California 91206, United States
Additional Information

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

Page last updated: August 23, 2015

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