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A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

NCT02128321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-05-01

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.

Conditions

  • Pharmacokinetics of Repaglinide
  • Pharmacokinetics of Caffeine
  • Healthy Subjects

Interventions

DRUG

Isavuconazole

oral

DRUG

Repaglinide

oral

DRUG

Caffeine

oral

Sponsors & Collaborators

  • Basilea Pharmaceutica International Ltd

    collaborator INDUSTRY

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

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 NCT02128321 on ClinicalTrials.gov