Radiolabelled IV and Oral Metabolism Study of F901318

NCT02912026 | Withdrawn Phase 1

• 1 other identifier: F901318-01-08-16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution. Blood, urine and faeces will be collected over a period adequate to obtain 90% recovery of parent compound and to determine the metabolic profile of both IV and oral forms.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Mass balance

  Metabolic profiling over 28 days

  28 days

Study Arms (2)

Intravenous

EXPERIMENTAL

Intravenous AUC0-infinity

Drug: IV F901318

Oral

EXPERIMENTAL

Oral AUC0-infinity

Drug: Oral F901318

Interventions

IV F901318 DRUG

Metabolic profile AUC 0 to infinity

Intravenous

Oral F901318 DRUG

Metabolic profile AUC 0 to infinity

Oral

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males who do not wish to father children within the 6 months following IMP administration.
• Age 40 to 65 years of age at the time of signing the ICF.
• Body mass index of 18.0 to 35.0 kg/m2, with a weight of 50 to 100 kg.
• Must be willing and able to communicate and participate in the whole study.
• Subjects must be in good health as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
• Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
• Must provide written informed consent and agree to abide by the study restrictions
• Must agree to use an adequate method of contraception during the study and for 6 months after study discharge

You may not qualify if:

• Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing.
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
• Subjects who have previously been enrolled in this study or have previously been exposed to F901318.
• History of any drug or alcohol abuse in the past 2 years.
• Regular alcohol consumption in males \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
• Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the last 6 months. A confirmed positive urine cotinine test at screening or admission.
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

olorofim

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: September 21, 2016
• First Posted: September 23, 2016
• Study Start: May 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 26, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)