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

Aristea Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy; ADME

Treatments: Drug: [14C]RIST4271

Study type: Interventional

Funder types: Industry

Identifiers

NCT05023811

RIST4721-104

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C]RIST4721

Experimental group

Description:

\[14C\]RIST4721 oral solution

Treatment:

Drug: [14C]RIST4271