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HealthyPhase 1NCT01494597

Drug Interaction Study of Isavuconazole and Cyclosporine

A Phase 1 study testing isavuconazole and cyclosporine in people with Healthy, run by Astellas Pharma Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
isavuconazole and cyclosporine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Nov 2011to Dec 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject must weigh at least 45 kg and have a body mass index (BMI) of 18 to 32 kg/m2, inclusive
  • The subject has a normal 12-lead electrocardiogram (ECG)
  • The subject's clinical laboratory test results are within normal limits
  • Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin must be within the normal range
  • If female, the subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years without menses), or using a medically acceptable double barrier method (eg, spermicide and diaphragm, spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until three weeks after the follow up visit at the end of study; and is not lactating or pregnant as documented by negative serum pregnancy tests
  • If male, the subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period and for three weeks after the follow up visit at the end of the study

Who cannot join

  • Any clinically significant (as judged by the Investigator) disease history of the following systems: pulmonary, gastrointestinal, cardio-vascular (including a history of clinically significant arrhythmia or clinically significant conduction delays on ECG), hepatic, neuro-logical, psychiatric, renal, genitourinary, endocrine, metabolic, dermatologic, immunologic, hematologic, or malignancy excluding non melanoma skin cancer
  • The subject has a history of, or has active psoriasis
  • 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)
  • History of tuberculosis or exposure to anyone known or suspected to have tuberculosis or any illness that might confound the results of the study or pose additional risk in administering study drug to the subject
  • The subject has/had a 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 or plans to receive any vaccinations within 2 weeks after the last dose of study drug
Show all 16Show fewer
  • The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies, or QuantiFERON®-TB Gold test(s) 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 prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over-the-counter medication within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
  • The subject has received an experimental agent within 30 days or 5 half-lives, whichever is longer, prior to Day -1
  • 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 has taken part in strenuous exercise within 3 days before dosing in this trial
  • The subject anticipates an inability to abstain from caffeine or alcohol use for 48 hours prior to clinic admission 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 to clinic admission and throughout the duration of the study
  • The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug screen
  • The subject has any other condition which precludes the subject's participation in the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Cyclosporine: A Phase 1, Open-Label, Sequential Study in Healthy Adult Subjects

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects.

Read the detailed description

Subjects will be enrolled to receive a single dose of cyclosporine on Day 1 followed by a 10-day wash-out period (time from cyclosporine dosing to isavuconazole dosing). On Days 11 and 12, isavuconazole will be dosed three times daily (TID). On Days 13 through 18, isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of cyclosporine on Day 15. Subjects will be confined in the study center from Day -1 until Day 5 and from Day 10 until Day 19.

A follow up visit will be scheduled approximately 7 ± 2 days after final dosing of isavuconazole.

Blood and urine samples will be taken at various times during the study.

Conditions
Healthy
Being tested
isavuconazole, cyclosporine
Keywords
Isavuconazole, Cyclosporine, Healthy Volunteers, BAL8557, Pharmacokinetics of isavuconazole, Pharmacokinetics of cyclosporine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isavuconazoleDrug

    Also called BAL8557

    oral

  • cyclosporineDrug

    Also called Neoral

    oral

Study groups in NCT01494597
Study groupRoleWhat they receive
Isavuconazole and cyclosporineExperimentalIsavuconazole three times per day (TID) for two days followed by once a day (QD) for 6 days. Cyclosporine single doses on Days 1 and 15.
Receives: Drug: isavuconazole; Drug: cyclosporine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Pharmacokinetic (PK) variables for cyclosporine (in whole blood): 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), Cmax

    Measured: Days 1 and 15

Secondary outcomes (3)

  1. Composite of PK variables for cyclosporine (in whole blood): 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 (t 1/2)

    Measured: Days 1 and 15

  2. PK variable for Isavuconazole (in plasma): trough concentration (Ctrough)

    Measured: Day 13 and Days 17 through 19

  3. Composite of PK variables for Isavuconazole (in plasma): AUC during time interval between consecutive dosing (AUCtau), maximum concentration (Cmax),and time to attain Cmax (tmax)

    Measured: Days 14 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494597
Sponsor's protocol ID
9766-CL-0022
Status last verified
Dec 2011
First submitted
15 Dec 2011
Last updated
19 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing isavuconazole and cyclosporine in people with Healthy, run by Astellas Pharma Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Pharmacokinetic (PK) variables for cyclosporine (in whole blood): 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), Cmax (time frame: Days 1 and 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01494597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.

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