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A Study to Evaluate ACT-246475 Fate in Healthy Male Subjects

NCT03593278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-07-03

No results posted yet for this study

Summary

The purpose of this study is to investigate how quickly and to what extent ACT-246475 is absorbed, distributed, metabolized (broken down) and eliminated from the body. ACT-246475 will be labeled with 14-Carbon (14C) and, in this way can be traced in blood, urine, and feces. This study will also investigate how safe is ACT-246475 and how well it is tolerated when administered to healthy male volunteers.

Conditions

  • Healthy Subjects

Interventions

DRUG

ACT-246475

Single s.c. dose of 16 mg ACT-246475 including 3.7 MBq (100 μCi) 14C-radiolabeled ACT 246475

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2018-08-05
Completion
2018-08-05
FDA Drug
Yes

Countries

  • Germany

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 NCT03593278 on ClinicalTrials.gov