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

NCT01555866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-09-01

No results posted yet for this study

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

Interventions

DRUG

isavuconazole

IV

Sponsors & Collaborators

  • Basilea Pharmaceutica International Ltd

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555866 on ClinicalTrials.gov