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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-11

Study Completion Date

2021-09-15

Brief Summary

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A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]RIST4721 Following a Single Oral Dose to Healthy Male Subjects

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Detailed Description

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Conditions

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Healthy ADME

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[14C]RIST4721

\[14C\]RIST4721 oral solution

Group Type EXPERIMENTAL

[14C]RIST4271

Intervention Type DRUG

\[14C\]RIST4271 oral solution

Interventions

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[14C]RIST4271

\[14C\]RIST4271 oral solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes