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

Part of paid clinical trials in Tustin, California.

Sponsor
F2G Biotech GmbH
Study ID
NCT04752540
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 2, 2021
Status verified
Mar 2022
Primary completion
Oct 24, 2021
Completion
Oct 24, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mild hepatic impairment
    120 mg olorofim
  • Experimental: Moderate hepatic impairment
    60 to 120 mg olorofim
  • Active Comparator: Normal hepatic function
    120 mg olorofim

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t) [ Time Frame: 0-96 hours ]

Locations (2)

FacilityCityStateZIPSite coordinators
Orange County Research CentreTustinCalifornia92780-
Orlando Clinical Research CentreOrlandoFlorida32809-

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