Mass Balance Recovery, Absorption, Metabolism and Excreti... | NCT05244759

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

NCT05244759

Sponsor

Bellus Health Inc. - a GSK company

Status

Completed

Last Update Posted

Feb 17, 2022Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Healthy

Interventions

[14C]-BLU-5937

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2020Actual

Primary Completion Date

Sep 23, 2020Actual

Completion Date

Mar 2, 2021Actual

First Submitted Date

Feb 11, 2022

First Submission Date that Met QC Criteria

Feb 11, 2022

First Posted Date

Feb 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2022

Last Update Posted Date

Feb 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Single oral dose of [14C]-BLU-5937	Drug: [14C]-BLU-5937

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[14C]-BLU-5937	Drug	Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	168 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Sciences		Nottingham	Ruddington	NG11 6JS	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided