Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

NCT01555866 | Completed Phase 1

• 1 other identifier: 9766-CL-0018
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.

Conditions

Pharmacokinetics of Isavuconazole; Healthy Volunteers; Renal Impaired

Keywords

isavuconazole; BAL4815; BAL8557; BAL8728

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics variables for BAL4815 (in plasma): AUC72 and Cmax

  Area under the concentration-time curve from 0 to 72 hours (AUC72) and Maximum concentration (Cmax)

  Day 1, Part 1

• Pharmacokinetics variables for BAL4815 (in plasma): AUCinf, AUClast, and Cmax

  Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), Area under the plasma concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)

  Day 1, Part 2

Secondary Outcomes (7)

• Pharmacokinetics variables for BAL4815 (in plasma): AUCinf and AUClast

  Day 1, Part 1

• Pharmacokinetics variables for BAL4815 (in plasma): tmax, t1/2, Vz, and CLtot , Ae, Ae% , CLR

  Day 1, Parts 1 and 2

• Pharmacokinetics unbound (u) variables for BAL4815 (in plasma and in urine): AUC inf,u, AUC72,u, AUClast,u, Cmax,u, Vz,u, CLtot,u, CLR,u

  Day 1, Parts 1 and 2

• Pharmacokinetics variables for End Stage Renal Disease (ESRD) subjects for BAL4815: AUC72, Cmax, and tmax

  Day 15, Part 1

• Pharmacokinetics variables for BAL8728 (in plasma and urine): AUCinf, AUClast, AUC72, Cmax, tmax , t1/2, Vz, CLtot, Ae, Ae% , CLR

  Day 1, Parts 1 and 2

Study Arms (6)

Part 1 Subjects with End Stage Renal Disease (ESRD)

EXPERIMENTAL

Drug: isavuconazole

Part 1 Healthy Subjects

EXPERIMENTAL

Drug: isavuconazole

Part 2 Subjects with Mild Renal Impairment

EXPERIMENTAL

Drug: isavuconazole

Part 2 Subjects with Moderate Renal Impairment

EXPERIMENTAL

Drug: isavuconazole

Part 2 Subjects with Severe Renal Impairment

EXPERIMENTAL

Drug: isavuconazole

Part 2 Subjects with no Renal Impairment

EXPERIMENTAL

Drug: isavuconazole

Interventions

isavuconazole DRUG

IV

Also known as: BAL4815, BAL8557

Part 1 Healthy Subjects; Part 1 Subjects with End Stage Renal Disease (ESRD); Part 2 Subjects with Mild Renal Impairment; Part 2 Subjects with Moderate Renal Impairment; Part 2 Subjects with Severe Renal Impairment; Part 2 Subjects with no Renal Impairment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must weigh at least 45 kg and have a body mass index of 18-35 kg/m2
• If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until 28 days after final study dug administration. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -1
• If male, the 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 during the study and until 90 days after the end of the study
• The subject has good venous access
• Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after final study drug administration.

You may not qualify if:

• The subject has a previous history of any clinically significant gastro-intestinal, neurological, hepatic, pulmonary, metabolic, dermatologic, immunologic, cardiovascular, psychiatric, genitourinary, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that would preclude participation in the study
• The subject has evidence of any cardiac conduction abnormalities
• The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome
• The subject has a supine systolic blood pressure less than 90 or greater than 160 mmHg, and diastolic blood pressure less than 50 or greater than 90 mmHg, or pulse rate less than 40 or greater than 100 beats per minute, either at Screening and Day -1
• The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day -1. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)
• The subject has a positive test for alcohol or drugs of abuse at Screening or Day-1, unless it is an expected result due to an approved concomitant medication for subjects with renal impairment
• The subject has used nicotine patches or any tobacco-containing products within 1 month prior to Day-1 or is a smoker, defined as greater than 10 cigarettes per week
• The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Screening, or over-the-counter medication within 14 days prior to Screening (with the exception of acetaminophen up to 2 grams/day)
• The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours prior to Day -1 and throughout the duration of the study
• The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to Day -1 and throughout the duration of the study
• The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to Day -1
• The subject has been vaccinated within the last 30 days prior to Screening
• The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen at Screening or a known history of human immunodeficiency virus
• The subject has a known or suspected hypersensitivity to isavuconazole, the azole class of compounds, or any components of the study drugs
• The subject has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to Screening

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Basilea Pharmaceutica International Ltd: collaborator

Study Sites (3)

DaVita Research

Denver, Colorado, 80228, United States

Location

Clinical Pharmacology Miami

Miami, Florida, 33014, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

isavuconazole

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

US (3)