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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752540
• Other study ID #: F901318-01-16
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2021
• Est. completion date: October 24, 2021

Study information

• Verified date: March 2022
• Source: F2G Biotech GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Olorofim
single oral dose

Locations

Country	Name	City	State
United States	Orlando Clinical Research Centre	Orlando	Florida
United States	Orange County Research Centre	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
F2G Biotech GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)		0-96 hours
Primary	Maximum Observed Plasma Concentration (Cmax)		0-96 hours
Secondary	Time to Reach Maximum Plasma Concentration (Tmax)		0-96 hours
Secondary	Apparent Elimination Half Life (t1/2)		0-96 hours
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)		0-96 hours
Secondary	Number of Participants With Treatment-Emergent Adverse Events		10 days