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Levoketoconazole Food Effect Study in Healthy Subjects

NCT03768388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-02-04

No results posted yet for this study

Summary

This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.

Conditions

  • Healthy Subjects

Interventions

DRUG

levoketoconazole

food effect

Sponsors & Collaborators

  • Cortendo AB

    lead INDUSTRY

Principal Investigators

  • Steven Schoenfeld, MD · Cortendo AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2018-12-24
Completion
2018-12-24
FDA Drug
Yes

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 NCT03768388 on ClinicalTrials.gov