A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
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 2021
Shorter than P25 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
First Submitted
Initial submission to the registry
August 11, 2021
CompletedStudy Start
First participant enrolled
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedJanuary 10, 2022
January 1, 2022
1 month
August 11, 2021
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
Mass balance recovery of total radioactivity in all excreta: CumAe
Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Ae
Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
Day 1 to Day 17
Collection of plasma, urine and fecal samples for metabolite profiling
Day 1 to Day 17
Collection of plasma, urine and fecal samples for structural identification
Day 1 to Day 17
Collection of plasma, urine and fecal samples for quantification analysis
Day 1 to Day 17
Study Arms (1)
[14C]RIST4721
EXPERIMENTAL\[14C\]RIST4721 oral solution
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males
- Must provide written informed consent
- Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
- Weight ≥50 kg and ≤100 kg inclusive at screening
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
You may not qualify if:
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Evidence of current SARS-CoV-2 infection
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences Ltd
Nottingham, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 27, 2021
Study Start
August 11, 2021
Primary Completion
September 15, 2021
Study Completion
September 15, 2021
Last Updated
January 10, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share