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

Bellus Health Inc. - a GSK company6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]-BLU-5937DRUG

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

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Sciences

Nottingham, Ruddington, United Kingdom

Outcomes

Primary Outcomes

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

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

Time frame: 168 hour

Data from ClinicalTrials.gov

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