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

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 Overview

• Status: Completed
• Conditions: Healthy; ADME
• Intervention / Treatment: Drug: [14C]RIST4271

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient Sciences Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [14C]RIST4721; [14C]RIST4721 oral solution	Drug: [14C]RIST4271; [14C]RIST4271 oral solution

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Aristea Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2021
• Primary Completion (ACTUAL): September 15, 2021
• Study Completion (ACTUAL): September 15, 2021

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (ACTUAL): August 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RIST4721-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes