- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128893
A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
April 30, 2014 updated by: Astellas Pharma Global Development, Inc.
A Phase 1 Randomized Open Label, Parallel Group Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
The purpose of this study is to assess the effect of multiple doses of esomeprazole on the pharmacokinetics of isavuconazole.
In addition, safety and tolerability of isavuconazole alone and in combination with esomeprazole will be assessed
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21225
- PAREXEL Early Phase Clinical Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject has a body weight of at least 50 kg and a body mass index of 18.5 to 32 kg/m2, inclusive
- The subject's 12-lead electrocardiogram (ECG) is normal
- The subject's clinical laboratory test results are within normal limits
Exclusion Criteria:
- The 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
- The subject has a history of bowel obstruction, swallowing disorder, severe gastro-intestinal disorders, major gastrointestinal surgery, gastric/duodenal ulcers or any other condition that may interfere with study drug absorption
- Female subject has been pregnant within 6 months before screening or breast feeding within 3 months before screening
- The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes). QT is the time between the start of the Q wave and the end of the T wave in the heart's electrical system
- The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission
- The subject has received a vaccination within the last 30 days prior to study drug administration
- The subject has a positive serology test for Hepatitis B surface antigen (HBsAg), Hepatitis A Immunoglobulin M antibody (anti HAV (IgM)), Hepatitis C antibody (anti-HCV), or human immunodeficiency virus (anti-HIV 1+2)
- The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions
- The subject has used tobacco or nicotine containing products in the last 6 months
- The subject has had treatment with any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior with the exception of hormonal methods of contraception, hormone replacement therapy, or occasional use of acetaminophen up to 2 g/day
- The subject has participated in any interventional clinical study or has received any investigational drugs within past 30 days or 5 half-lives, whichever is longer
- 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 anticipates an inability to abstain from alcohol or caffeine use for 48 hours prior and throughout the duration of the study; or from grapefruit, grapefruit juice, star fruit, or Seville oranges or any products containing these items from 72 hours prior and throughout the duration of the study
- The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
- The subject has taken part in strenuous exercise within 3 days before Day 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isavuconazole alone
Isavuconazole three times a day on Days 1 and 2 and once a day on Days 3, 4, and 5
|
oral
Other Names:
|
Experimental: Isavuconazole and Esomeprazole
Esomeprazole daily for 10 days starting on Day 1 and isavuconazole three times a day on Days 6 and 7 and once a day on Days 8, 9, and 10
|
oral
Other Names:
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau)
Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2)
|
Day 5 (Arm 1) and Day 10 (Arm 2)
|
|
Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax)
Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2)
|
Day 5 (Arm 1) and Day 10 (Arm 2)
|
|
Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax)
Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2)
|
Day 5 (Arm 1) and Day 10 (Arm 2)
|
|
Safety assessed through adverse events
Time Frame: up to Day 17
|
up to Day 17
|
|
Safety assessed through clinical laboratory evaluations
Time Frame: up to Day 11
|
Laboratory assessments will include hematology, serum chemistry and urinalysis parameters
|
up to Day 11
|
Safety assessed by 12-lead electrocardiograms (ECGs)
Time Frame: up to Day 11
|
up to Day 11
|
|
Safety assessed through vital signs
Time Frame: up to Day 11
|
Vital signs will be measured including oral temperature, pulse, and sitting blood pressure
|
up to Day 11
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
April 30, 2014
First Submitted That Met QC Criteria
April 30, 2014
First Posted (Estimate)
May 1, 2014
Study Record Updates
Last Update Posted (Estimate)
May 1, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9766-CL-0054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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