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

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.

Timeline

Start

2020-09-30

Primary completion

2020-10-29

Completion

2020-10-29

Publications

• Schulz SI, Schultze-Mosgau MH, Engelen A, Singh N, Pawsey S, Francke K, Lock R, Rottmann A. Mass Balance Recovery, Absorption, Metabolism, and Excretion of Elinzanetant in Healthy Human Volunteers and in vitro Biotransformation. Eur J Drug Metab Pharmacokinet. 2025 Jan;50(1):91-103. doi: 10.1007/s13318-024-00930-3. Epub 2024 Dec 24.

Drugs

Indications

No indication recorded.