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

NCT05006118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-07-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Altavant Sciences, Inc.

    collaborator UNKNOWN

  • Covance

    collaborator INDUSTRY

  • Altavant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • John E Blanchard, MD · Covance Clinical Research Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05006118 on ClinicalTrials.gov