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Completed

NCT Number: NCT05023811

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

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Key information

Conditions

Healthy ADME

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Ltd

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]RIST4271

Drug

[14C]RIST4271 oral solution

Primary outcomes

  1. Mass balance recovery of total radioactivity in all excreta: CumAe

    Time frame: Day 1 to Day 17

  2. Mass balance recovery of total radioactivity in all excreta: Cum%Ae

    Time frame: Day 1 to Day 17

  3. Determination of routes and rates of elimination of [14C]RIST4721 by Ae

    Time frame: Day 1 to Day 17

  4. Determination of routes and rates of elimination of [14C]RIST4721 by %Ae

    Time frame: Day 1 to Day 17

  5. Determination of routes and rates of elimination of [14C]RIST4721 by CumAe

    Time frame: Day 1 to Day 17

  6. Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval

    Time frame: Day 1 to Day 17

  7. Collection of plasma, urine and fecal samples for metabolite profiling

    Time frame: Day 1 to Day 17

  8. Collection of plasma, urine and fecal samples for structural identification

    Time frame: Day 1 to Day 17

  9. Collection of plasma, urine and fecal samples for quantification analysis

    Time frame: Day 1 to Day 17

Sponsors and collaborators

Lead sponsor

Aristea Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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