CompletedNCT05023811Updated Jan 10, 2022

A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects

A Phase 1 interventional study of [14C]RIST4271 in Healthy and ADME, sponsored by Aristea Therapeutics, Inc.. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Aristea Therapeutics, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Sep 2021, 5 years ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 6
Allocation: Not applicable
Ages: 30 Years to 65 Years
Sex: Male

Study 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

Conditions studied

Healthy
ADME

In context

Lead sponsor

Aristea Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 65 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 6 participants (actual)

Study arms

Experimental
[14C]RIST4721
\[14C\]RIST4721 oral solution
Drug: [14C]RIST4271

Interventions

Drug[14C]RIST4271
\[14C\]RIST4271 oral solution

What researchers measure

Primary outcomes

Mass balance recovery of total radioactivity in all excreta: CumAe
Time frame: Day 1 to Day 17
Mass balance recovery of total radioactivity in all excreta: Cum%Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
Time frame: Day 1 to Day 17
Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for metabolite profiling
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for structural identification
Time frame: Day 1 to Day 17
Collection of plasma, urine and fecal samples for quantification analysis
Time frame: Day 1 to Day 17

Study locations

1 site

Quotient Sciences Ltd
Nottingham, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05023811
Lead sponsor: Aristea Therapeutics, Inc.
Responsible party: Sponsor
First posted: Aug 27, 2021
Start date: Aug 11, 2021
Primary completion: Sep 15, 2021
Completion: Sep 15, 2021
Last update: Jan 10, 2022

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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