Pharmacokinetics of IsavuconazolePhase 1NCT01884636
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
A Phase 1 study testing isavuconazole and methotrexate in people with Pharmacokinetics of Isavuconazole and Pharmacokinetics of Methotrexate, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole will be assessed alone and in combination with methotrexate. 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 Isavuconazole, Pharmacokinetics of Methotrexate, Pharmacokinetics of 7-hydroxymethotrexate
- What is being tested?
- isavuconazole and methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 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.
- QTcF must be 360 to 430 msec.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and serum creatinine must not be above the normal range.
- Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration.
- Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
Who cannot join
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or 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 has a known or suspected immunodeficiency syndrome.
- The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies or QuantiFERON®-TB Gold test(s) 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, 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 any prescribed or non-prescribed drugs in the 2 weeks prior to Day 1, with the exception of occasional use of acetaminophen up to 2 g/day.
Show all 10Show fewer
- The subject has participated in any interventional clinical study or has received any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to Screening.
- The subject has participated in a prior study with isavuconazole.
- The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening or the subject tests positive at screening or Day -1 for alcohol or drugs of abuse.
- The subject is an employee of the Astellas Group or vendors involved in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91026
About this study
Official title: A Phase 1, Open- Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole will be assessed alone and in combination with methotrexate.
Read the detailed description
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10.
A follow-up telephone call will be made on Day 16 to check on health status.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methotrexate, Pharmacokinetics of 7-hydroxymethotrexate, Healthy Subjects
- Being tested
- isavuconazole, methotrexate
- Keywords
- Isavuconazole, Pharmacokinetics, Healthy Subjects, BAL8557, BAL4815, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isavuconazoleDrug
Also called BAL8557
oral
methotrexateDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| isavuconazole and methotrexate | Experimental | Methotrexate single dose on days 1 and 8. Isavuconazole three times a day (TID) on days 4 and 5 followed by isavuconazole once daily (QD) on days 6 - 9 Receives: Drug: isavuconazole; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of methotrexate in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast)
Measured: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: AUC from the time of dosing to infinity (AUCinf)
Measured: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: Maximum Concentration (Cmax)
Measured: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
Secondary outcomes (4)
PK variable for isavuconazole in plasma: Trough Concentration (Ctrough)
Measured: Days 6, 9 and 10 (1 sample prior to isavuconazole dosing)
Composite of PK variables for isavuconazole in plasma: AUCtau, Cmax and tmax
AUC during the time interval between consecutive dosing (AUCtau); the time after dosing when Cmax occurs (tmax)
Measured: Days 7 and 8 (13 samples collected per day)
Composite of PK variables for methotrexate in plasma: t1/2, tmax, CL/F and Vz/F
Apparent Terminal Elimination Half-life (t1/2); Apparent Body Clearance After Oral Dosing (CL/F); Apparent Volume of Distribution (Vz/F)
Measured: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
Composite of PK variables for 7- hydroxymethotrexate in plasma: AUClast, AUCinf, t1/2, Cmax and tmax
Measured: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of IsavuconazoleStudies 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
- 24 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884636
- Sponsor's protocol ID
- 9766-CL-0052
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open- Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
- ClinicalTrials.gov ID
- NCT01884636
- Acronym / sponsor ID
- 9766-CL-0052
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methotrexate, Pharmacokinetics of 7-hydroxymethotrexate, Healthy Subjects
- Keywords
- Isavuconazole, Pharmacokinetics, Healthy Subjects, BAL8557, BAL4815, methotrexate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica International Ltd
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 24 Jun 2013 (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 assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole will be assessed alone and in combination with methotrexate.
Detailed description
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10.
A follow-up telephone call will be made on Day 16 to check on health status.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isavuconazole and methotrexate | Experimental | Drug: isavuconazole, Drug: methotrexateMethotrexate single dose on days 1 and 8. Isavuconazole three times a day (TID) on days 4 and 5 followed by isavuconazole once daily (QD) on days 6 - 9 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive.
- QTcF must be 360 to 430 msec.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and serum creatinine must not be above the normal range.
- Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration.
- Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
Key exclusion criteria (10 listed)
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or 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 has a known or suspected immunodeficiency syndrome.
- The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies or QuantiFERON®-TB Gold test(s) 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, 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.
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 |
|---|---|---|
| isavuconazoleAlso: BAL8557oral | Drug | isavuconazole and methotrexate |
| methotrexateoral | Drug | isavuconazole and methotrexate |
Primary outcome
Pharmacokinetics (PK) of methotrexate in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: AUC from the time of dosing to infinity (AUCinf)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
PK of methotrexate in plasma: Maximum Concentration (Cmax)
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
4 secondary outcomes
PK variable for isavuconazole in plasma: Trough Concentration (Ctrough)
Time frame: Days 6, 9 and 10 (1 sample prior to isavuconazole dosing)
Composite of PK variables for isavuconazole in plasma: AUCtau, Cmax and tmax
Time frame: Days 7 and 8 (13 samples collected per day)
Composite of PK variables for methotrexate in plasma: t1/2, tmax, CL/F and Vz/F
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
Composite of PK variables for 7- hydroxymethotrexate in plasma: AUClast, AUCinf, t1/2, Cmax and tmax
Time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)
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 24 Jun 2013.
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, Inc.
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 isavuconazole and methotrexate in people with Pharmacokinetics of Isavuconazole and Pharmacokinetics of Methotrexate, 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 5 inclusion and 10 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 24 Jun 2013. 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?
Pharmacokinetics (PK) of methotrexate in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast) (time frame: Days 1 and 8 (15 plasma samples obtained from time zero to 36 hours post dose)). The study lists 3 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 24 Jun 2013.