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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Olorofim

• Registration Number: NCT04752540
• Lead Sponsor: F2G Biotech GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-12
• Study Start: 2021-07-02
• Primary Completion: 2021-10-24
• Study Completion: 2021-10-24
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal hepatic function	Olorofim	120 mg olorofim
Mild hepatic impairment	Olorofim	120 mg olorofim
Moderate hepatic impairment	Olorofim	60 to 120 mg olorofim

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Time to Reach Maximum Plasma Concentration (Tmax)	0-96 hours

Trial Locations

Locations (2)

Orange County Research Centre; 🇺🇸 Tustin, California, United States

Orlando Clinical Research Centre; 🇺🇸 Orlando, Florida, United States