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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2020
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2021
CompletedFirst Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedFebruary 17, 2022
February 1, 2022
29 days
February 11, 2022
February 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Arm 1
EXPERIMENTALSingle oral dose of \[14C\]-BLU-5937
Interventions
Each subject will receive a single oral administration of \[14C\]-BLU-5937 capsule, in the fasted state.
Eligibility Criteria
You may qualify if:
- Healthy males
You may not qualify if:
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences
Nottingham, Ruddington, NG11 6JS, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 17, 2022
Study Start
August 25, 2020
Primary Completion
September 23, 2020
Study Completion
March 2, 2021
Last Updated
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share