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

F

F2G Biotech

Status and phase

Completed
Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: Olorofim

Study type

Interventional

Funder types

Industry

Identifiers

NCT04752540
F901318-01-16

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 3 patient groups

Mild hepatic impairment
Experimental group
Description:
120 mg olorofim
Treatment:
Drug: Olorofim
Moderate hepatic impairment
Experimental group
Description:
60 to 120 mg olorofim
Treatment:
Drug: Olorofim
Normal hepatic function
Active Comparator group
Description:
120 mg olorofim
Treatment:
Drug: Olorofim

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems