Drug Interaction Study of Isavuconazole and Digoxin
This study has been completed.
Sponsor:
Astellas Pharma Global Development, Inc.
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01582412
First received: April 19, 2012
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics of Isavuconazole Pharmacokinetics of Digoxin Healthy Volunteers |
Drug: Isavuconazole Drug: digoxin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Digoxin in Healthy Adult Subjects |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Pharmacokinetic (PK) profile for digoxin (in plasma):AUCinf, AUClast, Cmax [ Time Frame: Days 1 and 19 ] [ Designated as safety issue: No ]Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax)
Secondary Outcome Measures:
- PK profile for digoxin (in plasma): tmax, Vz/F, CL/F, and t1/2 [ Time Frame: Days 1 and 19 ] [ Designated as safety issue: No ]Time to attain Cmax(tmax), apparent volume of distribution (Vz/F), apparent body clearance after oral dosing (CL/F), and apparent terminal elimination half-life (t1/2)
- PK Isavuconazole (in plasma): trough concentration (Ctrough) [ Time Frame: Day 17 and Days 21 through 27 ] [ Designated as safety issue: No ]
- PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax [ Time Frame: Days 18 and 19 ] [ Designated as safety issue: No ]AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax)
- Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs. [ Time Frame: Day 1 through Day 34 (± 2 days) ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | March 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Isavuconazole and digoxin
Isavuconazole three times per day (TID) on Days 15 and 16, and once daily (QD) on Days 17 thru 26. Digoxin single dose on Days 1 and 19.
|
Drug: Isavuconazole
oral
Other Name: BAL8557
Drug: digoxin
oral
Other Name: Lanoxin®
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL
- The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
- The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study
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 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 C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
- The subject has a known or suspected allergy to any of the components of the trial products including digoxin or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions
- The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
- The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
- The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582412
Locations
| United States, Maryland | |
| Parexel International | |
| Baltimore, Maryland, United States, 21225 | |
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Basilea Pharmaceutica International Ltd
Investigators
| Study Director: | Medical Director | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01582412 History of Changes |
| Other Study ID Numbers: | 9766-CL-0025 |
| Study First Received: | April 19, 2012 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Isavuconazole Digoxin Healthy Volunteers BAL8557 |
Additional relevant MeSH terms:
|
Digoxin Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013