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

A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Olorofim

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32808
      • Omega Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
• Subjects with severe renal impairment (or End-Stage Renal Disease who are not on dialysis) and with an eGFR <30 mL/min, estimated using the Cockcroft-Gault equation at screening and Day -1
• Subjects with normal renal function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
• Subjects with normal renal function are matched by gender, age (±10 years) and BMI (± 20%) to at least one renally impaired subject.

Exclusion Criteria:

• Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
• Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
• Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
• Subjects with a history of or any concomitant active malignancy.
• Subjects with a history of drug or alcohol abuse.
• Subjects with, or with a history of, any clinically significant neurological, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
• Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
• Renally impaired subjects with kidney transplantation, or on dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe renal impairment; 120 mg olorofim	Drug: Olorofim; Single oral dose; Other Names: F901318
Active Comparator: Normal renal function; 120 mg olorofim	Drug: Olorofim; Single oral dose; Other Names: F901318

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)	0-96 hours
Maximum Observed Plasma Concentration (Cmax)	0-96 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Reach Maximum Plasma Concentration (Tmax)	0-96 hours
Apparent Elimination Half Life (t1/2)	0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)	0-96 hours
Number of Participants With Treatment-Emergent Adverse Events	10 days

Collaborators and Investigators

• Sponsor: F2G Biotech GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Anti-Infective Agents; Antifungal Agents; Olorofim
• Other Study ID Numbers: F901318-01-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No