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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05244759

Enrollment

Registered

2022-02-17

Start date

2020-08-25

Completion date

2021-03-02

Last updated

2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUG[14C]-BLU-5937

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026