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

NCT ID: NCT05244759

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-03-02

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Single oral dose of \[14C\]-BLU-5937

Group Type EXPERIMENTAL

[14C]-BLU-5937

Intervention Type DRUG

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

Interventions

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[14C]-BLU-5937

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quotient Sciences

Nottingham, Ruddington, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BUS-P1-03

Identifier Type: -

Identifier Source: org_study_id

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