Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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) c...
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 rando...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04096157
Start Date
September 24 2019
End Date
January 16 2020
Last Update
November 20 2024
Active Locations (1)
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1
Parexel International
Baltimore, Maryland, United States, 21225