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Trial record 19 of 1177 for:    MYCOPHENOLIC ACID

A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT01711489
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : October 22, 2012
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.

Condition or disease Intervention/treatment Phase
Healthy Subjects Pharmacokinetics of Isavuconazole Pharmacokinetics of Plasma Mycophenolic Acid (MPA) Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG) Drug: isavuconazole Drug: Mycophenolate mofetil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Experimental: isavuconazole and mycophenolate mofetil
Single dose of MMF on Day 1, isavuconazole three times daily (TID) on Days 9 and 10, isavuconazole once daily (QD) Days 11-16, a single dose of MMF on Day 13
Drug: isavuconazole
oral
Other Name: BAL4815

Drug: Mycophenolate mofetil
oral
Other Name: CellCept, MMF




Primary Outcome Measures :
  1. Composite of pharmacokinetic (PK) variables of plasma mycophenolic acid (MPA) and phenolic glucuronide of MPA (MPAG): AUClast, AUCinf, Cmax [ Time Frame: Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose ]
    Area under the concentration-time curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast), AUC from the time of dosing to infinity (AUCinf), and maximum concentration (Cmax)


Secondary Outcome Measures :
  1. PK of plasma isavuconazole: Trough concentration (Ctrough) [ Time Frame: Day 11, Days 14-16, predose and on Day 17, predose and 24 hours postdose ]
  2. Composite of PK variables of plasma isavuconazole concentration: AUCtau, Cmax, and tmax [ Time Frame: Days 12 and 13: predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, and 24 hours postdose ]
    AUC during the time interval between consecutive dosing (AUCtau), time to attain Cmax (tmax)

  3. Composite of PK variables of plasma MPA: tmax, t1/2, Vz/F, and CL/F [ Time Frame: Days 1 and 13: 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 ]
    Apparent terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), and apparent body clearance after oral dosing (CL/F)

  4. Composite of PK variables of plasma MPAG: tmax and t1/2 [ Time Frame: Days 1 and 13: predose, and at 0.5, .75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose ]
  5. Safety assessed through the reporting of adverse events, laboratory evaluations, electrocardiograms (ECGs) and vital signs [ Time Frame: Through Day 17 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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) must be ≤ 1.5 mg/dL
  • 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 5 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 5 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 tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject.
  • The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen, or QuantiFERON®-TB Gold test 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 mycophenolate mofetil (MMF) or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711489


Locations
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United States, California
Parexel International, LLC
Glendale, California, United States, 91206
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Basilea Pharmaceutica International Ltd
Investigators
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Study Director: Senior Medical Director Astellas Pharma Global Development

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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01711489     History of Changes
Other Study ID Numbers: 9766-CL-0030
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
isavuconazole
mycophenolate mofetil (MMF)
BAL8557
BAL4815
healthy volunteers
Mycophenolic acid (MPA)
Phenolic glucuronide of MPA (MPAG)
CellCept
Additional relevant MeSH terms:
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Mycophenolic Acid
Isavuconazole
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents