Hematological MalignancyPhase 1NCT03241550
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
A Phase 1 study testing isavuconazonium sulfate - intravenous and isavuconazonium sulfate - oral in people with Hematological Malignancy, run by Astellas Pharma Global Development, Inc. at 16 sites in United States.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Hematological Malignancy
- What is being tested?
- isavuconazonium sulfate - intravenous and isavuconazonium sulfate - oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 16 sitesUnited States
- Study dates
- 2 Oct 2017to 5 Jul 2019
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
- Female subject must either:
- Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile
- Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
- Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
- Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
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- Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
- Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and, for 90 days after the final study drug administration.
- Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment.
- For oral cohorts: subject is able to swallow the oral capsule medication.
Who cannot join
- Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
- Subject has evidence of hepatic dysfunction defined as:
- Total bilirubin ≥ 3 times the upper limit of normal (ULN)
- Alanine transaminase or aspartate transaminase ≥ 5 times the ULN
- Known cirrhosis or chronic hepatic failure
- Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
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- Subject has known history of allergy, hypersensitivity, or any serious reaction to any of the azole class antifungals.
- Subject has any condition which makes the subject unsuitable for study participation.
- Subject is unlikely to survive 30 days.
- Subject has received investigational therapy, with the exception of oncology drug trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.
- For oral cohorts: The subject has gastrointestinal disease or has had a procedure that is expected to interfere with the oral absorption or tolerance of the study drug (e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or frequent vomiting).
- Subject previously dosed with isavuconazonium sulfate.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospital of Cleveland
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Miller Children's Hospital
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Louisville
Louisville, Kentucky, 40202
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
The Children's Hospital at TriStar Centennial Medical Center
Nashville, Tennessee, 37203
CHOC Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
- Conditions
- Hematological Malignancy
- Being tested
- isavuconazonium sulfate - intravenous, isavuconazonium sulfate - oral
- Keywords
- invasive fungal disease, Cresemba®, Hematological malignancy, isavuconazonium sulfate, ASP9766, isavuconazole, pediatric population
- Medical subject headings
- Hematologic Neoplasms, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isavuconazonium sulfate - intravenousDrug
Also called Cresemba®
IV infusion
isavuconazonium sulfate - oralDrug
Also called Cresemba®
Oral
| Study group | Role | What they receive |
|---|---|---|
| isavuconazonium sulfate IV cohort 1: 1 to < 6 years of age | Experimental | Patients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). Receives: Drug: isavuconazonium sulfate - intravenous |
| isavuconazonium sulfate IV cohort 2: 6 to < 12 years of age | Experimental | Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). Receives: Drug: isavuconazonium sulfate - intravenous |
| isavuconazonium sulfate IV cohort 3: 12 to < 18 years of age | Experimental | Patients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). Receives: Drug: isavuconazonium sulfate - intravenous |
| isavuconazonium sulfate oral cohort 4: 6 to < 12 years of age | Experimental | Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). Receives: Drug: isavuconazonium sulfate - oral |
| isavuconazonium sulfate oral cohort 5: 12 to < 18 years of age | Experimental | Patients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). Receives: Drug: isavuconazonium sulfate - oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state
Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.
Measured: Up to 7 days
PK of isavuconazole in plasma: AUCtau
Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.
Measured: Up to 7 days
PK of isavuconazole in plasma: tmax
Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.
Measured: Up to 7 days
PK of isavuconazole in plasma: Ctrough
Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.
Measured: Up to 28 days
PK of isavuconazole in plasma: CL
Clearance (CL) will be model-derived.
Measured: Up to 28 days
PK of isavuconazole in plasma: Vss
Volume of distribution at steady state (Vss) will be model-derived.
Measured: Up to 28 days
PK of isavuconazole in plasma: AUCss
Area under the concentration-time curve at steady state (AUCss) will be model-derived.
Measured: Up to 28 days
PK of isavuconazole in plasma: t 1/2
Half-life (t1/2) will be model-derived.
Measured: Up to 28 days
Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.
Measured: Up to 58 days
Number of patients with vital sign abnormalities and/or adverse events
An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Measured: Up to 28 days
Number of patients with laboratory value abnormalities and/or adverse events
An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Measured: Up to 28 days
Safety assessed by routine 12- lead electrocardiogram (ECG)
Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start2 Oct 2017
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignancyStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241550
- Sponsor's protocol ID
- 9766-CL-0046
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2017
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Arrieta AC, Neely M, Day JC, Rheingold SR, Sue PK, Muller WJ, Danziger-Isakov LA, Chu J, Yildirim I, McComsey GA, Frangoul HA, Chen TK, Statler VA, Steinbach WJ, Yin DE, Hamed K, Jones ME, Lademacher C, Desai A, Micklus K, Phillips DL, Kovanda LL, Walsh TJ. Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0029021. doi: 10.1128/AAC.00290-21. Epub 2021 Jul 16.
PubMed 34031051
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03241550
- Acronym / sponsor ID
- 9766-CL-0046
- Conditions
- Hematological Malignancy
- Keywords
- invasive fungal disease, Cresemba®, Hematological malignancy, isavuconazonium sulfate, ASP9766, isavuconazole, pediatric population
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Basilea Pharmaceutica International Ltd
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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 the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| isavuconazonium sulfate IV cohort 1: 1 to < 6 years of age | Experimental | Drug: isavuconazonium sulfate - intravenousPatients will receive an intravenous (IV) loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). |
| isavuconazonium sulfate IV cohort 2: 6 to < 12 years of age | Experimental | Drug: isavuconazonium sulfate - intravenousPatients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). |
| isavuconazonium sulfate IV cohort 3: 12 to < 18 years of age | Experimental | Drug: isavuconazonium sulfate - intravenousPatients will receive an IV loading regimen of isavuconazonium sulfate, which consists of a dose every 8 hours (+/- 2 hours) on days 1 and 2, followed by once daily IV maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). |
| isavuconazonium sulfate oral cohort 4: 6 to < 12 years of age | Experimental | Drug: isavuconazonium sulfate - oralPatients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). |
| isavuconazonium sulfate oral cohort 5: 12 to < 18 years of age | Experimental | Drug: isavuconazonium sulfate - oralPatients will receive a loading regimen of isavuconazonium sulfate by oral administration, comprising one dose every 8 hours (+/- 2 hours) on days 1 and 2 (a total of six doses), followed by once daily oral maintenance dosing for up to 26 additional days (for a maximum of 28 days of dosing). |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
- Female subject must either:
- Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
- Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
- Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
Key exclusion criteria (12 listed)
- Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
- Subject has evidence of hepatic dysfunction defined as:
- Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
- Subject has known history of allergy, hypersensitivity, or any serious reaction to any of the azole class antifungals.
- Subject has any condition which makes the subject unsuitable for study participation.
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 |
|---|---|---|
| isavuconazonium sulfate - intravenousAlso: Cresemba®IV infusion | Drug | isavuconazonium sulfate IV cohort 1: 1 to < 6 years of age, isavuconazonium sulfate IV cohort 2: 6 to < 12 years of age, isavuconazonium sulfate IV cohort 3: 12 to < 18 years of age |
| isavuconazonium sulfate - oralAlso: Cresemba®Oral | Drug | isavuconazonium sulfate oral cohort 4: 6 to < 12 years of age, isavuconazonium sulfate oral cohort 5: 12 to < 18 years of age |
Primary outcome
Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state
Time frame: Up to 7 days
Maximum concentration at steady state (Cmax) will be derived from the PK plasma samples collected.
PK of isavuconazole in plasma: AUCtau
Time frame: Up to 7 days
Area under the concentration time curve from the time of dosing to the start of next dosing interval at multiple dose conditions (AUCtau) will be derived from the PK plasma samples collected.
PK of isavuconazole in plasma: tmax
Time frame: Up to 7 days
Time of maximum concentration (tmax) will be derived from the PK plasma samples collected.
PK of isavuconazole in plasma: Ctrough
Time frame: Up to 28 days
Concentration - trough level (Ctrough) will be derived from the PK plasma samples collected.
PK of isavuconazole in plasma: CL
Time frame: Up to 28 days
Clearance (CL) will be model-derived.
PK of isavuconazole in plasma: Vss
Time frame: Up to 28 days
Volume of distribution at steady state (Vss) will be model-derived.
PK of isavuconazole in plasma: AUCss
Time frame: Up to 28 days
Area under the concentration-time curve at steady state (AUCss) will be model-derived.
PK of isavuconazole in plasma: t 1/2
Time frame: Up to 28 days
Half-life (t1/2) will be model-derived.
Safety assessed by nature, frequency and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 58 days
A TEAE is defined as an Adverse Event (AE) observed after starting administration of the study drug through follow-up. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). Number of patients with TEAE's will be summarized.
Number of patients with vital sign abnormalities and/or adverse events
Time frame: Up to 28 days
An abnormality identified during a medical test (e.g. vital signs) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Number of patients with laboratory value abnormalities and/or adverse events
Time frame: Up to 28 days
An abnormality identified during a medical test (e.g. laboratory parameter) should be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of study drug; or the abnormality or test value is clinically significant.
Safety assessed by routine 12- lead electrocardiogram (ECG)
Time frame: Up to 28 days
Standard 12-lead ECG recordings will be used for the purposes of safety assessment. A 12-lead, resting ECG is to be recorded. Patients should remain supine for at least 5 minutes prior to all ECGs being performed. The results (normal, abnormal not clinically significant, abnormal clinically significant) are to be recorded.
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 19 Nov 2024.
- Derived from this study: PubMed 34031051Arrieta AC, Neely M, Day JC, Rheingold SR, Sue PK, Muller WJ, Danziger-Isakov LA, Chu J, Yildirim I, McComsey GA, Frangoul HA, Chen TK, Statler VA, Steinbach WJ, Yin DE, Hamed K, Jones ME, Lademacher C, Desai A, Micklus K, Phillips DL, Kovanda LL, Walsh TJ. Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients. Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0029021. doi: 10.1128/AAC.00290-21. Epub 2021 Jul 16.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Senior Medical Director study director
Astellas Pharma Global Development, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isavuconazonium sulfate - intravenous and isavuconazonium sulfate - oral in people with Hematological Malignancy, run by Astellas Pharma Global Development, Inc. at 16 sites 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 10 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 isavuconazole in plasma: Cmax at steady state (time frame: Up to 7 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241550, which also lists 1 linked publication.
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 19 Nov 2024.