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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05023811

Enrollment

Registered

2021-08-27

Start date

2021-08-11

Completion date

2021-09-15

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADME, Healthy

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

Interventions

DRUG[14C]RIST4271

\[14C\]RIST4271 oral solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026