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

Part of paid clinical trials in Orlando, Florida.

Sponsor
F2G Biotech GmbH
Study ID
NCT05200286
Phase
PHASE1
Status
Completed

Conditions

  • Renal 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 subjects with severe renal impairment compared to subjects with normal renal function.

Key Dates

Start date
Feb 10, 2022
Status verified
Jan 2023
Primary completion
Dec 13, 2022
Completion
Dec 13, 2022

Study Design

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

Arms

  • Experimental: Severe renal impairment
    120 mg olorofim
  • Active Comparator: Normal renal 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 (1)

FacilityCityStateZIPSite coordinators
Omega ResearchOrlandoFlorida32808-

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By research site
Omega Research· Orlando, FL

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