A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mild hepatic impairment 120 mg olorofim |
Drug: Olorofim
single oral dose
Other Names:
|
| Experimental: Moderate hepatic impairment 60 to 120 mg olorofim |
Drug: Olorofim
single oral dose
Other Names:
|
| Active Comparator: Normal hepatic function 120 mg olorofim |
Drug: Olorofim
single oral dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orange County Research Centre | Tustin | California | United States | 92780 |
| 2 | Orlando Clinical Research Centre | Orlando | Florida | United States | 32809 |
Sponsors and Collaborators
- F2G Biotech GmbH
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F901318-01-16