Pharmacokinetics of 14C-labeled Isavuconazonium SulfatePhase 1NCT02059590
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
A Phase 1 study testing Pyridinylmethyl-14C-labeled isavuconazonium sulfate in people with Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate, Healthy Subjects
- What is being tested?
- Pyridinylmethyl-14C-labeled isavuconazonium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Pyridinylmethyl-14C-labeled isavuconazonium sulfate
- Keywords
- 14C-labeled isavuconazonium sulfate, Pyridinylmethyl-14C-labeled isavuconazonium sulfate, Healthy Subjects, BAL8728, BAL4815
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyridinylmethyl-14C-labeled isavuconazonium sulfateDrug
Also called BAL8557
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Pyridinylmethyl-14C-labeled isavuconazonium sulfate | Experimental | single dose Receives: Drug: Pyridinylmethyl-14C-labeled isavuconazonium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity in whole blood and in plasma: Area under the concentration-time curve (AUC) from time of dosing to infinity (AUCinf)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After study drug administration up to Day 9
Radioactivity ratio blood/plasma
Measured: Day 1
Percent of dose and cumulative percent of dose of radioactivity recovered in urine
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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%)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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 outcomes (1)
Metabolic profile of BAL8728 and possible metabolites in plasma, urine, and feces
Measured: Up to 3 days (72 hours) after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of 14C-labeled Isavuconazonium SulfateStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica International Ltd
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059590
- Sponsor's protocol ID
- 9766-CL-0050
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02059590
- Acronym / sponsor ID
- 9766-CL-0050
- Keywords
- 14C-labeled isavuconazonium sulfate, Pyridinylmethyl-14C-labeled isavuconazonium sulfate, Healthy Subjects, BAL8728, BAL4815
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica International Ltd
- Study start
- Apr 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyridinylmethyl-14C-labeled isavuconazonium sulfate | Experimental | Drug: Pyridinylmethyl-14C-labeled isavuconazonium sulfatesingle dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyridinylmethyl-14C-labeled isavuconazonium sulfateAlso: BAL8557Intravenous | Drug | Pyridinylmethyl-14C-labeled isavuconazonium sulfate |
Primary outcome
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
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
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
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
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
Radioactivity in emesis (if applicable)
Time frame: After study drug administration up to Day 9
Radioactivity ratio blood/plasma
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
1 secondary outcome
Metabolic profile of BAL8728 and possible metabolites in plasma, urine, and feces
Time frame: Up to 3 days (72 hours) after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pyridinylmethyl-14C-labeled isavuconazonium sulfate in people with Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.