Clinical trial NCT04752540: A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Official title: A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: F2G Biotech GmbH
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
timeFrame: 0-96 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0-96 hours
Secondary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 0-96 hours
measure: Apparent Elimination Half Life (t1/2)
timeFrame: 0-96 hours
measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)
timeFrame: 0-96 hours
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: 10 days
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Centre
state: California
city: Orlando
country: United States
facility: Orlando Clinical Research Centre
state: Florida
Study officials:
References: