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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023811
• Other study ID #: RIST4721-104
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2022
• Source: Aristea Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ADME
• Healthy

Intervention

Drug:
• [14C]RIST4271
[14C]RIST4271 oral solution

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Ltd	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Aristea Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance recovery of total radioactivity in all excreta: CumAe		Day 1 to Day 17
Primary	Mass balance recovery of total radioactivity in all excreta: Cum%Ae		Day 1 to Day 17
Primary	Determination of routes and rates of elimination of [14C]RIST4721 by Ae		Day 1 to Day 17
Primary	Determination of routes and rates of elimination of [14C]RIST4721 by %Ae		Day 1 to Day 17
Primary	Determination of routes and rates of elimination of [14C]RIST4721 by CumAe		Day 1 to Day 17
Primary	Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval		Day 1 to Day 17
Primary	Collection of plasma, urine and fecal samples for metabolite profiling		Day 1 to Day 17
Primary	Collection of plasma, urine and fecal samples for structural identification		Day 1 to Day 17
Primary	Collection of plasma, urine and fecal samples for quantification analysis		Day 1 to Day 17