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Antifungal Agent

Olorofim for Kidney Failure

Phase 1
Waitlist Available
Research Sponsored by F2G Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-96 hours
Awards & highlights

Study Summary

This trial examined the effects of a new medication on people with different levels of kidney function.

Eligible Conditions
  • Kidney Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-96 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
Maximum Observed Plasma Concentration (Cmax)
Secondary outcome measures
Apparent Elimination Half Life (t1/2)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)
Number of Participants With Treatment-Emergent Adverse Events
+1 more

Side effects data

From 2014 Phase 1 trial • 40 Patients • NCT02142153
17%
Paraesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
F901318 0.75 mg/kg
F901318 1.5 mg/kg
0.25 mg/kg Placebo
F901318 0.25 mg/kg
Placebo 0.75 mg/kg
Placebo 3 mg/kg
F901318 3 mg/kg
Placebo 1.5 mg/kg
Placebo 4 mg/kg
F901318 4 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Severe renal impairmentExperimental Treatment1 Intervention
120 mg olorofim
Group II: Normal renal functionActive Control1 Intervention
120 mg olorofim
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olorofim
2021
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

F2G Biotech GmbHLead Sponsor
20 Previous Clinical Trials
1,820 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
2022. "A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05200286.
~5 spots leftby Apr 2025
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