A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects
- Registration Number
- NCT05023811
- Lead Sponsor
- Aristea Therapeutics, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]RIST4721 [14C]RIST4271 \[14C\]RIST4721 oral solution
- Primary Outcome Measures
Name Time Method 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 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 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 Collection of plasma, urine and fecal samples for metabolite profiling Day 1 to Day 17
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences Ltd
🇬🇧Nottingham, United Kingdom