Pharmacokinetics of IsavuconazolePhase 1NCT01565720
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
A Phase 1 study testing Isavuconazole and Moxifloxacin in people with Pharmacokinetics of Isavuconazole and Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. 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, Healthy Volunteers
- What is being tested?
- Isavuconazole and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2012
- 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
- Subject must weigh at least 45 kg and have a body mass index of 18-30 kg/m2
- If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -3
- If male, the 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 during the study and until two weeks after the end of the study
- The subject's clinical laboratory test results at Screening and Day -3 are within normal limits or any abnormal results are considered not to be clinically significant
- The subject has a sitting systolic blood pressure between 90 and 140 mmHg, inclusive and diastolic blood pressure between 50 and 90 mmHg, inclusive at Screening and Day -3
- The subject has good venous access
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 or any other medical condition that would preclude participation in the study
- The subject has evidence of any cardiac conduction abnormalities
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome or Short QT syndrome
- The subject has potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
- The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day 3. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)
- The subject has a history of drug, chemical, or substance abuse within the past 2 years prior to Screening or has a positive test at Screening or Day -3 for drugs of abuse
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- The subject has used tobacco-containing products or nicotine-containing products within 3 months prior to Screening
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Screening, or over-the-counter medication within 7 days prior to Screening (with the exception of acetaminophen up to 2 grams/day)
- The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours prior to Day -3 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 Day -3 and throughout the duration of the study
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to Day -3
- The subject has been vaccinated within the last 30 days prior to Screening
- The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen at Screening or a known history of human immunodeficiency virus
- The subject has known or suspected hypersensitivity to any of the quinolone antibiotics or a history of tendonitis and/or liver function abnormality related to quinolone antibiotic treatment
- The subject has a known or suspected hypersensitivity to isavuconazole, the azole class of compounds, or any components of the study drugs
- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to Screening
- The subject has had any significant blood loss, donated one or more units (450 mL) of blood or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to Day -3
- The subject has any other condition, which in the opinion of the investigator, 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, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.
- Being tested
- Isavuconazole, Placebo, Moxifloxacin
- Keywords
- Isavuconazole, Healthy Volunteers, BAL8557
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsavuconazoleDrug
Also called BAL8557
oral
PlaceboDrug
oral
MoxifloxacinDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole low dose once a day (QD) for 11 days Receives: Drug: Isavuconazole |
| Group 2 | Experimental | Isavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole high dose once a day (QD) for 11 days Receives: Drug: Isavuconazole |
| Group 3 | Placebo comparator | Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 11 days Receives: Drug: Placebo |
| Group 4 | Active comparator | Placebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 10 days and then moxifloxacin on Day 13 Receives: Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT interval corrected for heart rate using Fridericia's correction (QTcF)
Measured: Baseline and Day 13
Secondary outcomes (1)
Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate
Measured: Baseline and Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 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
- NCT01565720
- Sponsor's protocol ID
- 9766-CL-0017
- Status last verified
- Jul 2012
- First submitted
- 27 Mar 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01565720
- Acronym / sponsor ID
- 9766-CL-0017
- Keywords
- Isavuconazole, Healthy Volunteers, BAL8557
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica International Ltd
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Mar 2012 (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.
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: IsavuconazoleIsavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole low dose once a day (QD) for 11 days |
| Group 2 | Experimental | Drug: IsavuconazoleIsavuconazole low dose 3 times per day (TID) for 2 days followed by isavuconazole high dose once a day (QD) for 11 days |
| Group 3 | Placebo comparator | Drug: PlaceboPlacebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 11 days |
| Group 4 | Active comparator | Drug: Placebo, Drug: MoxifloxacinPlacebo 3 times a day (TID) for 2 days followed by placebo once a day (QD) for 10 days and then moxifloxacin on Day 13 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must weigh at least 45 kg and have a body mass index of 18-30 kg/m2
- If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -3
- If male, the 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 during the study and until two weeks after the end of the study
- The subject's clinical laboratory test results at Screening and Day -3 are within normal limits or any abnormal results are considered not to be clinically significant
- The subject has a sitting systolic blood pressure between 90 and 140 mmHg, inclusive and diastolic blood pressure between 50 and 90 mmHg, inclusive at Screening and Day -3
Key exclusion criteria (18 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 or any other medical condition that would preclude participation in the study
- The subject has evidence of any cardiac conduction abnormalities
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome or Short QT syndrome
- The subject has potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
- The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day 3. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)
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 | Group 1, Group 2 |
| Placebooral | Drug | Group 3, Group 4 |
| Moxifloxacinoral | Drug | Group 4 |
Primary outcome
Change from baseline in QT interval corrected for heart rate using Fridericia's correction (QTcF)
Time frame: Baseline and Day 13
1 secondary outcome
Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate
Time frame: Baseline and 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 9 Jul 2012.
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 Moxifloxacin in people with Pharmacokinetics of Isavuconazole and Healthy Volunteers, 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 6 inclusion and 18 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 9 Jul 2012. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in QT interval corrected for heart rate using Fridericia's correction (QTcF) (time frame: Baseline and Day 13). 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 9 Jul 2012.