Clinical Trials Directory

Trials / Completed

CompletedNCT04002895

What the Body Does to Foliglurax in Healthy Volunteers

Interventional, Open-label, Single-dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Foliglurax (Lu AF99757) Following Oral Dosing of 14C-foliglurax to Healthy Men

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
6 (actual)
Sponsor
H. Lundbeck A/S · Industry
Sex
Male
Age
45 Years – 60 Years
Healthy volunteers
Accepted

Summary

This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.

Detailed description

Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.

Conditions

Interventions

TypeNameDescription
DRUGFoligluraxSingle oral dose of 80 mg \[14C\]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from \[14C\]-foliglurax powder for oral solution)

Timeline

Start date
2019-06-27
Primary completion
2019-08-01
Completion
2019-08-08
First posted
2019-07-01
Last updated
2019-11-04

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04002895. Inclusion in this directory is not an endorsement.