Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male Subjects

Healthy Clinical Trial

Official title: A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-NT-814 in Healthy Male Subjects After Oral Dosing

Status Completed

Clinical Trial Summary

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-NT-814 in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 120 mg [14C] NT-814 containing not more than (NMT) 5.6 megabecquerel (MBq) [14C], administered as an oral suspension in the fasted state. Subjects will remain in the study until a mass balance cumulative recovery of >90% and <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

Clinical Trial Description

Subjects will undergo preliminary screening procedures for the study up to 28 days before [14C]-NT-814 administration. Subjects will be admitted in the evening on the day prior to [14C]-NT-814 administration (Day -1) at which time further screening procedures will be undertaken to confirm eligibility. Subjects will be dosed in the morning of Day 1 following an overnight fast of a minimum of 8 hours.

It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% and <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.

This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the mass balance discharge criteria are achieved during the planned residency period, collection of all samples (blood, urine, and faeces) will be stopped and subjects will undergo discharge assessments. If mass balance discharge criteria have not been met by all subjects by Day 15, the residency period for the subjects not achieving the mass balance discharge criteria may be extended up to a maximum of 48 hours (i.e., up to Day 17). Blood, urine and faeces will be collected for 24 hour intervals during the extended residency period whilst the subjects are resident in the clinic.

If the mass balance discharge criteria are still not met by Day 17, subjects will enter a home collection phase during which they will collect 24-hour urine and faeces on a daily basis up until Day 24 (or until the criteria are met) and then on a weekly basis starting on Day 31 (until criteria met or Day 45 reached). During the period of weekly collection, mass balance cumulative recovery will be estimated by means of interpolation.

No additional collections will be performed for subjects who still do not meet the criteria on Day 45. Subjects entering the home collection phase will return on Day 19 ± 12 hours for blood sample collection. Discharge safety assessments will be performed at the time of actual discharge from the clinical unit. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT04654897
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2020
• Completion date: October 29, 2020