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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-02

Study Completion Date

2021-10-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mild hepatic impairment

120 mg olorofim

Group Type EXPERIMENTAL

Olorofim

Intervention Type DRUG

single oral dose

Moderate hepatic impairment

60 to 120 mg olorofim

Group Type EXPERIMENTAL

Olorofim

Intervention Type DRUG

single oral dose

Normal hepatic function

120 mg olorofim

Group Type ACTIVE_COMPARATOR

Olorofim

Intervention Type DRUG

single oral dose

Interventions

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Olorofim

single oral dose

Intervention Type DRUG

Other Intervention Names

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F901318

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes