Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937

This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of [14C]-BLU-5937.

Completed

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Key information

Conditions

Healthy

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, Ruddington, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy males

Exclusion criteria

History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator

Treatment and study plan

[14C]-BLU-5937

Drug

Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.

Primary outcomes

Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937

Time frame: 168 hour

Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in blood, urine and faeces samples.

Sponsors and collaborators

Lead sponsor

Bellus Health Inc. - a GSK company

Industry

Registry information

Official study title

A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937 in Healthy Male Subjects After Oral Dosing

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Feb 17, 2022
Registry last updated: Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed