NCT02912026

Radiolabelled IV and Oral Metabolism Study of F901318

An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-F901318 Administered Via the Intravenous and Oral Routes to Healthy Male Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: F2G Biotech GmbH · Industry
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of Day -1 prior to investigational medicinal product (IMP) administration, and will be dosed on the morning of Day 1. In Cohort 1 (Regimen A), subjects will be dosed after a light breakfast; to assess tolerability of the IV administration, the first subject will be dosed at least 30 min prior to dosing the second subject. All subsequent dosing of the IV formulation will be staggered by at least 15 min. In Cohort 2 (Regimen B), subjects will be dosed following an overnight fast with an appropriate interval between subjects based on logistical requirements. Subjects will remain resident in the clinic up to 336 h post-dose (Day 15). It is planned that subjects will return to the clinical unit for 2 further 24 h residency periods on Day 21 and Day 28 if discharge criteria outlined in this protocol are not met. It is planned that subjects will be released from the study as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. If this occurs earlier than Day 28, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects following the Day 28 return visit, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.

Conditions

• Invasive Aspergillosis

Interventions

Type	Name	Description
DRUG	IV F901318	Metabolic profile AUC 0 to infinity
DRUG	Oral F901318	Metabolic profile AUC 0 to infinity

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2016-09-23
• Last updated: 2019-07-26

Locations

1 site across 1 country: United Kingdom