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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Tustin, California, United States, 92780
      • Orange County Research Centre
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• 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 mild hepatic impairment will have grade A Child-Pugh score of 5 to 6 at screening and Day -1:
• Subjects with moderate hepatic impairment: will have grade B Child-Pugh score of 7 to 9 at screening and Day -1
• Subjects with normal liver 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 liver function are matched by gender, age (±10 years) and BMI (± 20%) to at least one hepatically 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, renal, 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
• Hepatically impaired subjects with liver transplantation, autoimmune liver disease, or drug-induced liver damage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mild hepatic impairment; 120 mg olorofim	Drug: Olorofim; single oral dose; Other Names: F901318
EXPERIMENTAL: Moderate hepatic impairment; 60 to 120 mg olorofim	Drug: Olorofim; single oral dose; Other Names: F901318
ACTIVE_COMPARATOR: Normal hepatic 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): July 2, 2021
• Primary Completion (ACTUAL): October 24, 2021
• Study Completion (ACTUAL): October 24, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (ACTUAL): February 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Anti-Infective Agents; Antifungal Agents; Olorofim
• Other Study ID Numbers: F901318-01-16

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