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

NCT04654897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

[14C]-NT-814

120 mg radioactive labeled elinzanetant (\[14C\]-NT-814) oral suspension containing NMT (not more than) 5.6 MBq (megabecquerel) \[14C\].

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Principal Investigators

  • Prinicipal Investigator · Quotient Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2020-10-29
Completion
2020-10-29
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654897 on ClinicalTrials.gov