CClinicalTrials.gg
Sign In
CompletedNCT01660477Updated Feb 23, 2015

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole

A Phase 1 interventional study of Isavuconazole and Lopinavir/ritonavir in Pharmacokinetics of Isavuconazole, Pharmacokinetics of Lopinavir/Ritonavir and Healthy Volunteers, sponsored by Astellas Pharma Global Development, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-23.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pharmacokinetics of Isavuconazole
  • Pharmacokinetics of Lopinavir/Ritonavir
  • Healthy Volunteers

Keywords

  • Isavuconazole
  • Lopinavir/ritonavir
  • Healthy Volunteers
  • BAL8557
  • Kaletra ®
03

In context

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Arm 1: isavuconazole only

    Isavuconazole three times per day (TID) on Days 1-2, and once daily (QD) on Days 3 thru 13

    Drug: Isavuconazole

  • Experimental
    Arm 2 : LPV/RTV only

    Lopinavir/ritonavir (LPV/RTV) twice daily (BID) on Days 1-12 and once on Day 13

    Drug: Lopinavir/ritonavir

  • Experimental
    Arm 3: isavuconazole and LPV/RTV

    Isavuconazole three times per day (TID) on Days 1-2, and once daily (QD) on Days 3 thru 13 in combination with lopinavir/ritonavir twice daily (BID) on Days 1-13

    Drug: Isavuconazole · Drug: Lopinavir/ritonavir

Interventions

  • DrugIsavuconazole

    oral

    Also known as: BAL8557

  • DrugLopinavir/ritonavir

    oral

    Also known as: KALETRA®

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic (PK) for isavuconazole: AUCtau

    (Arms 1 and 3) Area under the concentration time curve during the during time interval between consecutive dosing (AUCtau) (tau=24)

    Time frame: Part 1, Day 13: predose, 0.5, 1, 2, 3, 4, 6, 8,10,12,16, and 24 hours post-dose

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

    (Arms 2 and 3) Maximum concentration (Cmax)

    Time frame: Part 2, Day 13: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose

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

    (Arms 2 and 3) AUC during time interval between consecutive dosing (AUCtau) (tau=12)

    Time frame: Part 2, Day 13: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours post dose

Secondary outcomes

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

    (Arms 1 and 3)

    Time frame: Parts 1 and 2, Days 3, 5, 7, 9 and 11: pre-dose

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

    (Arms 1 and 3) Time to attain Cmax (tmax)

    Time frame: Parts 1 and 2, Day 13: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12,16, and 24 hours post-dose

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

    (Arms 2 and 3)

    Time frame: Part 2, Days 3, 5, 7, 9 and 11: pre-dose

  4. PK for lopinavir/ritonavir (in plasma): tmax

    (Arms 2 and 3)

    Time frame: Part 2, Day 13: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours post dose

  5. 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

    Time frame: Part 1, Days 1 - 20 ± 2

07

Study locations

1 site
  • Parexel International
    Glendale, California 91206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01660477
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Basilea Pharmaceutica International Ltd
Responsible party
Sponsor
First posted
Aug 8, 2012
Start date
Jun 2012
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 23, 2015

Study contacts

Medical Director
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Astellas Pharma Global Development, Inc.

Start the discussion