NCT05006118

Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl

An Open-Label Mass Balance Study to Investigate the Pharmacokinetics, Excretion, and Recovery of Single-Dose Oral [14C]-Rodatristat Ethyl in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study to evaluate the PK and excretion of a single oral dose of \[14C\]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days prior to dosing); a treatment phase (from dosing until discharge from the unit, a minimum of 7 days and a maximum of 14 days); and discharge procedures.

Detailed description

This is an open-label study to evaluate the PK and excretion of a single oral dose of \[14C\]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days prior to dosing); a treatment phase (from dosing until discharge from the unit, a minimum of 7 days and a maximum of 14 days); and discharge procedures. After meeting eligibility criteria, approximately 6 healthy male subjects will check into the clinical unit (Day -1), and the following morning, receive a single oral suspension of rodatristat ethyl 600 mg containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (μCi) of radioactivity (Day 1). After fasting 10 hours overnight, the dose will be administered with a standard-calorie meal. Following dosing, serial whole blood and plasma PK samples, and urine and feces will be collected until discharge. Subjects will stay in the clinic until at least Day 7. Subjects will be discharged if total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected. If not, subjects will remain in the clinic until these criteria are met but not longer than 15 days (which includes Day -1). Plasma and urine samples will be analyzed for total radioactivity, rodatristat ethyl, rodatristat, M15, and any other identified metabolites (if applicable). Blood and fecal samples will be analyzed for total radioactivity, rodatristat ethyl, rodatristat, and metabolite(s).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Radio-labeled rodatristat ethyl 600 mg	Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of \[12C\]-rodatristat ethyl and \[14C\]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity

Timeline

• Start date: 2021-09-23
• Primary completion: 2021-10-06
• Completion: 2021-10-06
• First posted: 2021-08-16
• Last updated: 2022-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study