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

NCT05200286 | Completed Phase 1 FDA Drug

• 1 other identifier: F901318-01-17
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

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 (2)

Severe renal impairment

EXPERIMENTAL

120 mg olorofim

Drug: Olorofim

Normal renal function

ACTIVE COMPARATOR

120 mg olorofim

Drug: Olorofim

Interventions

Olorofim DRUG

Single oral dose

Also known as: F901318

Normal renal function; Severe renal impairment

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 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.

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, 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

Sponsors & Collaborators

• F2G Biotech GmbH: lead

Study Sites (1)

Omega Research

Orlando, Florida, 32808, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

olorofim

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: January 18, 2022
• First Posted: January 20, 2022
• Study Start: February 10, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)