Healthy SubjectsPhase 1NCT04096157
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
A Phase 1 study testing Isavuconazonium sulfate IV and Isavuconazonium sulfate capsules in people with 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 bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Isavuconazonium sulfate IV and Isavuconazonium sulfate capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 16 Jan 2020
- 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 has a body mass index (BMI) range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final investigational product (IP) administration.
- Female subject must agree not to breastfeed starting at screening, throughout the study period and for 30 days after final IP administration.
- Female subject must not donate ova starting at first administration of IP, throughout the study period and for 30 days after final IP administration.
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- Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after final IP administration.
- Male subject must not donate sperm during the treatment period and for 30 days after final IP administration.
- Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy, throughout the study period and for 30 days after final IP administration.
- Subject agrees not to participate in another interventional study while participating in the present study.
Who cannot join
- Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to isavuconazonium sulfate or any components of the formulations used.
- Subject has had previous exposure with isavuconazonium sulfate.
- Subject has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) ≥ 1.5 upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
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- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality following the physical examination, ECG (including familial short QT syndrome) and protocol-defined clinical laboratory tests at screening or on day -1.
- Subject has a mean pulse of < 45 or > 90 bpm; mean systolic blood pressure (SBP) >140 mmHg; diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate after the subject has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Subject has a history of peptic or gastric ulcers.
- Subject has a history of sinus disease, sinus allergy, renoplasty or any surgery of the nose, septum or nasal passages or any other abnormality that could impact NG tube placement (e.g., nasal polyps).
- Subject has taken medication or substances via inhalation through the nasal passages within 3 months prior to screening.
- Subject has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP administration, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products, including corticosteroid products, local anesthetic spray and/or gel (2% Xylocaine) for NG tube placement, hormonal contraceptives and hormone replacement therapy (HRT).
- Subject has smoked, used tobacco-containing products and nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the subject tests positive for cotinine at screening or on day -1.
- Subject has a history of consuming > 14 units for male subjects or > 7 units for female subjects of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol at screening or on day -1.
- Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the subject tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1.
- Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
- Subject has consumed grapefruit, Seville oranges, grapefruit-containing products or Seville orange-containing products within 72 hours prior to day -1.
- Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
- Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin M [IgM]), hepatitis B core, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
- Subject has abnormal renal function indicated by creatinine above the ULN on day -1. In such a case, the assessment may be repeated once.
- Subject is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Crossover Study to Assess the Bioequivalence of Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Subjects
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.
Read the detailed description
Eligible participants will participate in 2 treatment periods separated by a washout of at least 30 days between investigational product (IP) administrations in each period. Participants will be randomized to 1 of 2 sequences. Participants will be admitted to the clinical unit on day -1 of each period and will be residential for 5 days/4 nights. Participants will receive a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) or isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions on day 1 of each period. Participants are to remain semirecumbent and avoid lying on either the left or right side for 4 hours postdose. Correct placement of the NG tube will be confirmed using X-ray radiography. Pharmacokinetic samples will be collected predose on day 1 of each period and at multiple time points postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on day 4 of each period on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. Participants will return for ambulatory visits to collect pharmacokinetic samples on days 8, 11, 15 and 21 of each period.
The study will be completed with an end-of-study visit (ESV). The ESV will take place 5 to 9 days after day 21 of period 2 or at early discontinuation from the study.
- Conditions
- Healthy Subjects
- Being tested
- Isavuconazonium sulfate IV, Isavuconazonium sulfate capsules
- Keywords
- Cresemba, isavuconazonium sulfate, isavuconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isavuconazonium sulfate IVDrug
Also called Cresemba
Intravenous (IV) via nasogastric (NG) tube
Isavuconazonium sulfate capsulesDrug
Also called Cresemba
Oral
| Study group | Role | What they receive |
|---|---|---|
| Isavuconazonium sulfate IV solution then capsules | Experimental | Participants will first receive a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) under fasting conditions on Day 1 of Period 1. After a washout period of 30 days, the participants then receive a single dose of isavuconazonium sulfate capsules (reference formulation) for oral administration under fasting conditions on Day 1 of Period 2. Receives: Drug: Isavuconazonium sulfate IV; Drug: Isavuconazonium sulfate capsules |
| Isavuconazonium sulfate capsules then IV solution | Experimental | Participants will first receive a single dose of isavuconazonium sulfate capsules (reference formulation) for oral administration under fasting conditions on Day 1 of Period 1. After a washout period of 30 days, the participants then receive a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) under fasting conditions on Day 1 of Period 2. Receives: Drug: Isavuconazonium sulfate IV; Drug: Isavuconazonium sulfate capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of isavuconazole in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
PK of isavuconazole in plasma: area under the concentration-time curve from 0 to 72 hours (AUC72)
AUC72 will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 3 postdose in each period
PK of isavuconazole in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
PK of isavuconazole in plasma: maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Secondary outcomes (9)
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. An AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Measured: Up to 61 days
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 32 days
Number of participants with vital sign abnormalities and/or adverse events
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 61 days
Pharmacokinetics (PK) of isavuconazole in plasma: area under the concentration-time curve extrapolated from time to infinity as a percentage of total AUC (AUCinf(%extrap))
(AUCinf(%extrap)) will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: apparent clearance (CL/F)
CL/F will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: terminal elimination half-life (t1/2)
t1/2 will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: time of maximum concentration (tmax)
tmax will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: lag time (tlag)
tlag will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: apparent volume of distribution during terminal phase after oral/intravenous administration (Vz/F)
Vz/F will be recorded from the PK plasma samples collected.
Measured: Predose on Day 1 and up to Day 21 postdose in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start24 Sep 2019
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096157
- Sponsor's protocol ID
- 9766-CL-0112
- Status last verified
- Nov 2024
- First submitted
- 18 Sep 2019
- Last updated
- 20 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/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Crossover Study to Assess the Bioequivalence of Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04096157
- Acronym / sponsor ID
- 9766-CL-0112
- Conditions
- Healthy Subjects
- Keywords
- Cresemba, isavuconazonium sulfate, isavuconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 19 Sep 2019 (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 this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.
Detailed description
Eligible participants will participate in 2 treatment periods separated by a washout of at least 30 days between investigational product (IP) administrations in each period. Participants will be randomized to 1 of 2 sequences. Participants will be admitted to the clinical unit on day -1 of each period and will be residential for 5 days/4 nights. Participants will receive a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) or isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions on day 1 of each period. Participants are to remain semirecumbent and avoid lying on either the left or right side for 4 hours postdose. Correct placement of the NG tube will be confirmed using X-ray radiography. Pharmacokinetic samples will be collected predose on day 1 of each period and at multiple time points postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on day 4 of each period on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. Participants will return for ambulatory visits to collect pharmacokinetic samples on days 8, 11, 15 and 21 of each period.
The study will be completed with an end-of-study visit (ESV). The ESV will take place 5 to 9 days after day 21 of period 2 or at early discontinuation from the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isavuconazonium sulfate IV solution then capsules | Experimental | Drug: Isavuconazonium sulfate IV, Drug: Isavuconazonium sulfate capsulesParticipants will first receive a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) under fasting conditions on Day 1 of Period 1. After a washout period of 30 days, the participants then receive a single dose of isavuconazonium sulfate capsules (reference formulation) for oral administration under fasting conditions on Day 1 of Period 2. |
| Isavuconazonium sulfate capsules then IV solution | Experimental | Drug: Isavuconazonium sulfate IV, Drug: Isavuconazonium sulfate capsulesParticipants will first receive a single dose of isavuconazonium sulfate capsules (reference formulation) for oral administration under fasting conditions on Day 1 of Period 1. After a washout period of 30 days, the participants then receive a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) under fasting conditions on Day 1 of Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Female subject must agree not to breastfeed starting at screening, throughout the study period and for 30 days after final IP administration.
- Female subject must not donate ova starting at first administration of IP, throughout the study period and for 30 days after final IP administration.
- Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 30 days after final IP administration.
Key exclusion criteria (24 listed)
- Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has any condition which makes the subject unsuitable for study participation.
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to isavuconazonium sulfate or any components of the formulations used.
- Subject has had previous exposure with isavuconazonium sulfate.
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 IVAlso: CresembaIntravenous (IV) via nasogastric (NG) tube | Drug | Isavuconazonium sulfate IV solution then capsules, Isavuconazonium sulfate capsules then IV solution |
| Isavuconazonium sulfate capsulesAlso: CresembaOral | Drug | Isavuconazonium sulfate IV solution then capsules, Isavuconazonium sulfate capsules then IV solution |
Primary outcome
Pharmacokinetics (PK) of isavuconazole in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
AUCinf will be recorded from the PK plasma samples collected.
PK of isavuconazole in plasma: area under the concentration-time curve from 0 to 72 hours (AUC72)
Time frame: Predose on Day 1 and up to Day 3 postdose in each period
AUC72 will be recorded from the PK plasma samples collected.
PK of isavuconazole in plasma: area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
AUClast will be recorded from the PK plasma samples collected.
PK of isavuconazole in plasma: maximum concentration (Cmax)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Cmax will be recorded from the PK plasma samples collected.
9 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to 61 days
Number of participants with laboratory value abnormalities and/or adverse events
Time frame: Up to 32 days
Number of participants with vital sign abnormalities and/or adverse events
Time frame: Up to 61 days
Pharmacokinetics (PK) of isavuconazole in plasma: area under the concentration-time curve extrapolated from time to infinity as a percentage of total AUC (AUCinf(%extrap))
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: apparent clearance (CL/F)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: terminal elimination half-life (t1/2)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: time of maximum concentration (tmax)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: lag time (tlag)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
Pharmacokinetics (PK) of isavuconazole in plasma: apparent volume of distribution during terminal phase after oral/intravenous administration (Vz/F)
Time frame: Predose on Day 1 and up to Day 21 postdose in each period
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 20 Nov 2024.
- 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.
Executive 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 Isavuconazonium sulfate IV and Isavuconazonium sulfate capsules in people with 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 10 inclusion and 24 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 20 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 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 isavuconazole in plasma: area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf) (time frame: Predose on Day 1 and up to Day 21 postdose in each period). The study lists 4 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 20 Nov 2024.