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

NCT04752540 | Completed Phase 1 FDA Drug

• 1 other identifier: F901318-01-16
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (3)

Mild hepatic impairment

EXPERIMENTAL

120 mg olorofim

Drug: Olorofim

Moderate hepatic impairment

EXPERIMENTAL

60 to 120 mg olorofim

Drug: Olorofim

Normal hepatic function

ACTIVE COMPARATOR

120 mg olorofim

Drug: Olorofim

Interventions

Olorofim DRUG

single oral dose

Also known as: F901318

Mild hepatic impairment; Moderate hepatic impairment; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• F2G Biotech GmbH: lead

Study Sites (2)

Orange County Research Centre

Tustin, California, 92780, United States

Location

Orlando Clinical Research Centre

Orlando, Florida, 32809, United States

Location

MeSH Terms

Interventions

olorofim

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 12, 2021
• Study Start: July 2, 2021
• Primary Completion: October 24, 2021
• Study Completion: October 24, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)