Absorption, Metabolism and Excretion of 14C-olorofim in Man

NCT04039880 | Completed Phase 1

• 1 other identifier: F901318-01-09
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg \[14C\]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).

Conditions

Invasive Fungal Infections

Outcome Measures

Primary Outcomes (2)

• Mass balance

  % dose recovered in urine and faeces

  28 days

• Metabolite profiling

  number of metabolites in plasma, urine and faeces \> 10% of circulating radioactivity

  15 days

Secondary Outcomes (7)

• biliary elimination

  5 days

• Maximum plasma concentration (Cmax) for olorofim, F902412 and total radioactivity

  15 days

• time of maximum plasma concentration (Tmax) for olorofim, F902412 and total radioactivity

  15 days

• elimination half life (t1/2) for olorofim, F902412 and total radioactivity

  15 days

• Area under plasma concentration curve (AUC) for olorofim, F902412 and total radioactivity

  15 days

Study Arms (2)

Cohort A (mass balance)

EXPERIMENTAL

evaluation of mass balance and metabolite profiling

Drug: Olorofim

Cohort B (biliary evaluation)

EXPERIMENTAL

evaluation of biliary elimination

Drug: Olorofim

Interventions

Olorofim DRUG

single oral dose (120 mg, 3.7 MBq)

Also known as: F901318

Cohort A (mass balance); Cohort B (biliary evaluation)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy males age 18 to 55 years of age with body mass index of 18 to 30 kg/m2 (inclusive), and a body weight of 50 to 100 kg (inclusive).
• Subjects must be in good health as determined by a medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is NOT acceptable).
• Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).

You may not qualify if:

• Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
• Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration
• Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration
• Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration
• Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the 3 months prior to check-in.
• Radiation exposure, including that from the present study exceeding 1 mSv in the last 12 months or 5 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• PRA Health Sciences: collaborator

Study Sites (1)

PRA Health Sciences

Groningen, 9728, Netherlands

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

olorofim

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Jan Jaap van Lier, MD

  PRA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 31, 2019
• Study Start: July 30, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)