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

Aristea Therapeutics, Inc.6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy ADME

Interventions

[14C]RIST4271DRUG

\[14C\]RIST4271 oral solution

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quotient Sciences Ltd

Nottingham, United Kingdom

Outcomes

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

Data from ClinicalTrials.gov

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