Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937
Sponsor
Bellus Health Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT05244759
Collaborator
(none)
6
1
1
6.2
1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date
:
Aug 25, 2020
Actual Primary Completion Date
:
Sep 23, 2020
Actual Study Completion Date
:
Mar 2, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Single oral dose of [14C]-BLU-5937 |
Drug: [14C]-BLU-5937
Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 65 Years
Sexes Eligible for Study:
Male
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quotient Sciences | Nottingham | Ruddington | United Kingdom | NG11 6JS |
Sponsors and Collaborators
- Bellus Health Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT05244759
Other Study ID Numbers:
- BUS-P1-03
First Posted:
Feb 17, 2022
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No