- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01884558
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
June 20, 2013 updated by: Astellas Pharma Global Development, Inc.
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin.
Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Subjects will check-in to the clinic on Day -1 and remain confined through completion of the study procedures on Day 10.
A follow-up telephone call will be made on Day 16 to check on health status.
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
-
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California
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Glendale, California, United States, 91026
- California Clinical Trials Medical Group
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-
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 45 kg and a body mass index of 18 to 32 kg/m2, inclusive.
- QTcF must be 360 to 430 msec for males and 370 to 450 msec for females
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and serum creatinine must not be above the normal range.
- Female subject is of non-childbearing potential or if of childbearing potential must use highly effective birth control from Screening through 28 days after the end of the study. Females must not be breastfeeding or donate ova from Screening through 20 days after the end of the study.
- Male subject must be using highly effective contraception from Screening through 90 days after final study drug administration. Male subject must not donate sperm starting at Screening through 90 days after final study drug administration.
Exclusion Criteria:
- 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).
- The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus.
- 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 is a smoker (any use of tobacco or nicotine containing products) in the last 6 months.
- The subject has had treatment with any prescribed or non-prescribed drugs in the 2 weeks prior to Day 1, with the exception of 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 30 days or 5 half-lives, whichever is longer, prior to Screening.
- The subject has participated in a prior study with isavuconazole.
- 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 or the subject tests positive at screening or Day -1 for alcohol or drugs of abuse.
- The subject is an employee of the Astellas Group or vendors involved in the study.
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: isavuconazole and metformin
Metformin single dose on days 1 and 8. Isavuconazole three times a day (TID) on Days 4 and 5 followed by isavuconazole once daily (QD) on Days 6-9.
|
oral
Other Names:
oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (PK) of metformin in plasma: Area Under the Concentration-Time Curve (AUC) from the time of dosing to the last quantifiable concentration (AUClast)
Time Frame: Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
|
Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
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PK of metformin in plasma: AUC from the time of dosing to infinity (AUCinf)
Time Frame: Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
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Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
|
PK of metformin in plasma: Maximum Concentration (Cmax)
Time Frame: Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
|
Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK variable for isavuconazole in plasma: Trough Concentration (Ctrough)
Time Frame: Days 6, 9 and 10 (1 sample prior to isavuconazole dosing)
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Days 6, 9 and 10 (1 sample prior to isavuconazole dosing)
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|
Composite of PK variables for isavuconazole in plasma: AUCtau, Cmax and tmax
Time Frame: Days 7 and 8 (13 samples collected per day)
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AUC during the time interval between consecutive dosing (AUCtau); the time after dosing when Cmax occurs (tmax)
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Days 7 and 8 (13 samples collected per day)
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Composite of PK variables for metformin in plasma: t1/2, tmax, CL/F and Vz/F
Time Frame: Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
|
Apparent Terminal Elimination Half-life (t1/2); Apparent Body Clearance After Oral Dosing (CL/F); Apparent Volume of Distribution (Vz/F)
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Days 1 and 8 (16 plasma samples obtained from time zero to 48 hours post dose)
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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
February 1, 2013
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
June 20, 2013
First Submitted That Met QC Criteria
June 20, 2013
First Posted (Estimate)
June 24, 2013
Study Record Updates
Last Update Posted (Estimate)
June 24, 2013
Last Update Submitted That Met QC Criteria
June 20, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9766-CL-0051
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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