Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937
February 11, 2022 updated by: Bellus Health Inc
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ruddington
-
Nottingham, Ruddington, United Kingdom, NG11 6JS
- Quotient Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Single oral dose of [14C]-BLU-5937
|
Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937
Time Frame: 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.
|
168 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
September 23, 2020
Study Completion (Actual)
March 2, 2021
Study Registration Dates
First Submitted
February 11, 2022
First Submitted That Met QC Criteria
February 11, 2022
First Posted (Actual)
February 17, 2022
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- BUS-P1-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.