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Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01657838
First received: August 2, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

August 2, 2012
August 2, 2012
May 2012
May 2012   (final data collection date for primary outcome measure)
Pharmacokinetic (PK) profile for isavuconazole (in plasma): AUClast , Cmax [ Time Frame: Day 1 (Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose ] [ Designated as safety issue: No ]
Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) and maximum concentration (Cmax)
Same as current
No Changes Posted
  • PK profile for isavuconazole (in plasma): AUCinf, tmax, CL/F, Vz/F, and t1/2 [ Time Frame: Day 1(Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), Time to attain Cmax (tmax), apparent body clearance after oral dosing (CL/F), apparent volume of distribution (Vz/F), and apparent terminal elimination half-life (t1/2)
  • PK for ketoconazole (in plasma): trough concentration (Ctrough) [ Time Frame: Day 2 (Arm 2): predose ] [ Designated as safety issue: No ]
  • PK profile for ketoconazole (in plasma): AUCtau, Cmax, and tmax [ Time Frame: Days 3 and 4: predose and 0.5,1, 2, 4, 6, 8,12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    AUC during time interval between consecutive dosing (AUCtau)
  • Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs [ Time Frame: Day 1 through Day 25 (± 2 days) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
A Phase 1, Randomized, Open-Label, Two-Arm, Parallel Group Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects

The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Pharmacokinetics of Isavuconazole
  • Pharmacokinetics of Ketoconazole
  • Healthy Adult Volunteers
  • Drug: Isavuconazole
    oral
    Other Names:
    • BAL4815
    • BAL8557
  • Drug: Ketoconazole
    oral
  • Experimental: Arm 1: isavuconazole only
    Single dose of isavuconazole on Day 1
    Intervention: Drug: Isavuconazole
  • Experimental: Arm 2: isavuconazole + ketoconazole
    Single dose of isavuconazole on Day 4 and ketoconazole twice daily (BID) for 24 days
    Interventions:
    • Drug: Isavuconazole
    • Drug: Ketoconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2012
May 2012   (final data collection date for primary outcome measure)

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) and total bilirubin must not be above 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 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 during the study period

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 positive result for hepatitis C antibodies or 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 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 occasionally use of ibuprofen
  • The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug and/or alcohol screen
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01657838
9766-CL-0040
No
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Astellas Pharma Global Development, Inc.
Basilea Pharmaceutica International Ltd
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP