Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | June 2012 |
| End Date: | October 2012 |
| Contact: | Astellas Pharma Global Development |
| Email: | clintrials.info@us.astellas.com |
| Phone: | 800-888-7704 |
A Phase 1, Open-Label, Parallel Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Multiple Doses of Lopinavir/Ritonavir and the Effects of Lopinavir/Ritonavir on the Pharmacokinetics of Multiple Doses of Isavuconazole in Healthy Adult Subjects
The purpose of this two part study is to assess the effect of multiple doses of
isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the
effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.
Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or
isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to
evaluate safety and tolerability and to establish the effect of multiple doses of
lopinavir/ritonavir on isavuconazole.
Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,
lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.
Inclusion Criteria:
- The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18
to 32 kg/m2, inclusive
- Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT),
total bilirubin, lipase, amylase, glucose and triglycerides must be within the normal
range
- 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 history of pancreatitis
- The subject has a positive result for hepatitis C antibodies, 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 lopinavir/ritonavir 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
- The subject has participated in a previous isavuconazole study
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