Trials / Completed
CompletedNCT03593278
A Study to Evaluate ACT-246475 Fate in Healthy Male Subjects
Single-center, Open-label Study With 14C-radiolabeled ACT-246475 to Investigate Its Mass Balance, Pharmacokinetics, and Metabolism Following Single Subcutaneous Administration to Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Viatris Innovation GmbH · Industry
- Sex
- Male
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ACT-246475 | Single s.c. dose of 16 mg ACT-246475 including 3.7 MBq (100 μCi) 14C-radiolabeled ACT 246475 |
Timeline
- Start date
- 2018-07-27
- Primary completion
- 2018-08-05
- Completion
- 2018-08-05
- First posted
- 2018-07-20
- Last updated
- 2025-07-03
Locations
3 sites across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03593278. Inclusion in this directory is not an endorsement.