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CompletedNCT01635972Updated Sep 1, 2015

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion

A Phase 1 interventional study of Isavuconazole and bupropion hydrochloride in Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion 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 2015-09-01.

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.

02

Conditions studied

  • Pharmacokinetics of Isavuconazole
  • Pharmacokinetics of Bupropion
  • Healthy Volunteers

Keywords

  • Isavuconazole
  • Bupropion
  • Bupropion hydrochloride
  • Healthy Volunteers
  • BAL8557
  • BAL4815
  • BAL8728
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 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

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 a positive result for hepatitis B surface antigen or 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 received an experimental agent within 30 days or 5 half-lives, whichever is longer, prior to Day -1
  • The subject has a history of suicidal behavior and/or ongoing suicidal ideation as assessed using C-SSRS (Columbia - Suicide Severity Rating Scale) at Screening or at Clinic Check-In (any response of "yes" to the Suicidal Ideation questions on the C-SSRS)
  • The subject has a current or past history of seizure disorder or epilepsy
  • The subject has a current or past history of depression, anorexia nervosa or bulimia
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Isavuconazole and bupropion

    Bupropion hydrochloride on Days 1 and 15, Isavuconazole three times per day (TID) on Days 8 and 9, and once daily (QD) on Days 10 thru 20.

    Drug: Isavuconazole · Drug: bupropion hydrochloride

Interventions

  • DrugIsavuconazole

    oral

    Also known as: BAL8557

  • Drugbupropion hydrochloride

    oral

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic (PK) profile for bupropion (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)

    Time frame: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose

Secondary outcomes

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

    Apparent terminal elimination half-life (t1/2), Time to attain Cmax (tmax), Apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F)

    Time frame: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose

  2. PK profile for hydroxybupropion (in plasma): AUCinf, AUClast, Cmax, t1/2, tmax

    Time frame: Day 1 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 48, 72,and 96 hours post-dose and Day 15 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,10,12,16, 20, 24, 48, 72, 96,120, and 144 hours post-dose

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

    AUC during time interval between consecutive dosing (AUCtau)

    Time frame: Days 14 and 15 at pre-dose and 0.5,1,1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 20 hours post-dose

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

    Time frame: Pre-dose on Days 10 through 13 and Days 16 through 19 and on Day 20: predose and 24 hours post-dose

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

    Time frame: Days 1 through 27 (± 2 days)

07

Study locations

1 site
  • Clinical Pharmacology of Miami
    Miami, Florida 33014, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01635972
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Basilea Pharmaceutica International Ltd
Responsible party
Sponsor
First posted
Jul 10, 2012
Start date
Jun 2012
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Sep 1, 2015

Study contacts

Medical Director
study director · Astellas Phama Global Development

Oversight

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

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

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