Pharmacokinetics of IsavuconazolePhase 1NCT01406171
Drug Interaction Study of Isavuconazole and Midazolam
A Phase 1 study testing Isavuconazole and Midazolam in people with Pharmacokinetics of Isavuconazole and Pharmacokinetics of Midazolam, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam, Healthy Volunteers
- What is being tested?
- Isavuconazole and Midazolam
- 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
- May 2011to Jun 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject agrees to sexual abstinence, is surgically sterile, is postmenopausal, or is using a medically acceptable method to prevent pregnancy during the study period
- The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
- The subject's has a normal 12-lead electrocardiogram (ECG)
- The subject is a non-smoker and has not used tobacco or nicotine products for a minimum of 6 months
- The subject's clinical laboratory test results are within normal limits
Who cannot join
- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer
- The subject has a known or suspected hypersensitivity to midazolam, isavuconazole, or the azole class of compounds
- The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of drug or alcohol abuse within the past 2 years, or has a positive screen for alcohol or drugs of abuse/illegal drugs (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over-the-counter medication within 1 week prior to study drug administration, with the exception of acetaminophen up to 2g/day
- The subject anticipates an inability to abstain from caffeine or alcohol use for 48 hours prior to clinic admission and throughout the duration of the study
- The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to clinic admission and throughout the duration of the study
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- The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission
- The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen or a known history of human immunodeficiency virus
- The subject has been vaccinated within 30 days prior to study drug administration
- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- 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
- The subject has any other condition which precludes the subject's participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects
The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
Read the detailed description
Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study.
Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12.
- Being tested
- Isavuconazole, Midazolam
- Keywords
- Isavuconazole, ASP9766, BAL8557, Midazolam, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsavuconazoleDrug
Also called ASP9766, BAL8557
oral
MidazolamDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Isavuconazole and Midazolam | Experimental | Isavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12 Receives: Drug: Isavuconazole; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment of AUC through the analysis of blood samples
Measured: Up to Day 13
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
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.
- 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 Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406171
- Sponsor's protocol ID
- 9766-CL-0023
- Status last verified
- Jul 2011
- First submitted
- 6 Jul 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01406171
- Acronym / sponsor ID
- 9766-CL-0023
- Keywords
- Isavuconazole, ASP9766, BAL8557, Midazolam, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Aug 2011 (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 determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
Detailed description
Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study.
Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isavuconazole and Midazolam | Experimental | Drug: Isavuconazole, Drug: MidazolamIsavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject agrees to sexual abstinence, is surgically sterile, is postmenopausal, or is using a medically acceptable method to prevent pregnancy during the study period
- The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
- The subject's has a normal 12-lead electrocardiogram (ECG)
- The subject is a non-smoker and has not used tobacco or nicotine products for a minimum of 6 months
- The subject's clinical laboratory test results are within normal limits
Key exclusion criteria (12 listed)
- The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer
- The subject has a known or suspected hypersensitivity to midazolam, isavuconazole, or the azole class of compounds
- The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of drug or alcohol abuse within the past 2 years, or has a positive screen for alcohol or drugs of abuse/illegal drugs (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over-the-counter medication within 1 week prior to study drug administration, with the exception of acetaminophen up to 2g/day
- The subject anticipates an inability to abstain from caffeine or alcohol use for 48 hours prior to clinic admission and throughout the duration of the study
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: ASP9766, BAL8557oral | Drug | Isavuconazole and Midazolam |
| MidazolamOral | Drug | Isavuconazole and Midazolam |
Primary outcome
Pharmacokinetic assessment of AUC through the analysis of blood samples
Time frame: Up to Day 13
Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples
Time frame: Up to Day 13
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 1 Aug 2011.
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 Isavuconazole and Midazolam in people with Pharmacokinetics of Isavuconazole and Pharmacokinetics of Midazolam, run by Astellas Pharma 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 12 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 1 Aug 2011. 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?
Pharmacokinetic assessment of AUC through the analysis of blood samples (time frame: Up to Day 13). The study lists 2 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 1 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.