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

NCT ID: NCT05200286

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-12-13

Brief Summary

A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Severe renal impairment

120 mg olorofim

Group Type: EXPERIMENTAL

Olorofim

Intervention Type: DRUG

Single oral dose

Normal renal function

120 mg olorofim

Group Type: ACTIVE_COMPARATOR

Olorofim

Intervention Type: DRUG

Single oral dose

Interventions

Olorofim

Single oral dose

Intervention Type: DRUG

Other Intervention Names

F901318

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 severe renal impairment (or End-Stage Renal Disease who are not on dialysis) and with an eGFR <30 mL/min, estimated using the Cockcroft-Gault equation at screening and Day -1
• Subjects with normal renal 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 renal function are matched by gender, age (±10 years) and BMI (± 20%) to at least one renally 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, hepatic, 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
• Renally impaired subjects with kidney transplantation, or on dialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

F2G Biotech GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Omega Research

Orlando, Florida, United States

Countries

United States

Other Identifiers

F901318-01-17

Identifier Type: -

Identifier Source: org_study_id