A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects

February 7, 2014 updated by: Astellas Pharma Global Development, Inc.

A Phase 1 Open-Label Mass Balance Study to Evaluate the Pharmacokinetics of BAL8728 After A Single Intravenous Dose of 14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 12-lead electrocardiogram (ECG) is normal at Screening and Day -1; or, if abnormal, the abnormality is not clinically significant. The ECG for the subject has a QTcF of at least 360 but not more than 430 msec.

Exclusion Criteria:

  • The subject has any clinically significant disease history of the following systems: pulmonary, gastrointestinal, cardiovascular (including a history of clinically significant arrhythmia), hepatic, neurological, psychiatric, renal, genitourinary, endocrine, metabolic, dermatologic, immunologic, hematologic, or malignancy excluding non melanoma skin cancer.
  • The subject has a positive test 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 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 has used tobacco or nicotine containing products in the last 6 months prior to Day -1.
  • The subject has had treatment with prescription drugs, over-the-counter medication, or complementary and alternative medicines within 14 days prior to Day -1, with the exception of occasional use of acetaminophen up to 2 g/day.
  • The subject has participated in any interventional clinical study or has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  • The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pyridinylmethyl-14C-labeled isavuconazonium sulfate
single dose
Drug: Pyridinylmethyl-14C-labeled isavuconazonium sulfate
Intravenous
Other Names:
  • BAL8557

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Radioactivity in whole blood and in plasma: Area under the concentration-time curve (AUC) from time of dosing to infinity (AUCinf)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Radioactivity in whole blood and in plasma: AUC from time of dosing to the last quantifiable concentration (AUClast)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Radioactivity in whole blood and in plasma: Maximum concentration (Cmax)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Radioactivity in whole blood and in plasma: Time to Attain Cmax (tmax)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Radioactivity in whole blood and in plasma: Apparent terminal elimination half-life (t1/2)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Radioactivity in emesis (if applicable)
Time Frame: After study drug administration up to Day 9
After study drug administration up to Day 9
Radioactivity ratio blood/plasma
Time Frame: Day 1
Day 1
Percent of dose and cumulative percent of dose of radioactivity recovered in urine
Time Frame: 7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
Percent of dose and cumulative percent dose of radioactivity recovered in feces
Time Frame: 4 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
4 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: AUCinf
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: AUClast
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: Cmax
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: tmax
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: total body clearance after intravenous dosing (CLtot)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: volume of distribution during terminal phase after intravenous dosing (Vz)
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in plasma: t 1/2
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in urine: amount excreted (Ae)
Time Frame: 7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in urine: percent of unchanged drug excreted into the urine (Ae%)
Time Frame: 7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
Pharmacokinetics of BAL8728 (cleavage product) in urine: renal clearance (CLr)
Time Frame: 7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
7 time intervals up to Day 4. If Day 4 is not the end of the study, sample collection will continue in 24 hour intervals until discharge up to Day 9
Pharmacokinetics of BAL4815 (isavuconazole) in plasma: AUClast
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL4815 (isavuconazole) in plasma: Cmax
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
Pharmacokinetics of BAL4815 (isavuconazole) in plasma: tmax
Time Frame: 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Metabolic profile of BAL8728 and possible metabolites in plasma, urine, and feces
Time Frame: Up to 3 days (72 hours) after dosing
Up to 3 days (72 hours) after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Basilea Pharmaceutica International Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9766-CL-0050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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