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A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment

NCT04752540 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-16

No results posted yet for this study

Summary

A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Olorofim

single oral dose

Sponsors & Collaborators

  • F2G Biotech GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2021-10-24
Completion
2021-10-24
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 NCT04752540 on ClinicalTrials.gov