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Healthy SubjectsPhase 1NCT03593278

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

A Phase 1 study testing ACT-246475 in people with Healthy Subjects, run by Viatris Innovation GmbH at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
ACT-246475
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesGermany
Study dates
27 Jul 2018to 5 Aug 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Main Inclusion Criteria:

  • Signed informed consent in the local language prior to any studymandated procedure,
  • Healthy male subjects aged between 45 and 65 years (inclusive) at screening,
  • No clinically significant findings on the physical examination at screening,
  • Body mass index of 18.0-28.0 kg/m2 (inclusive) at screening,
  • Systolic blood pressure (BP) 100-140 mmHg, diastolic BP 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening,
  • 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening,
  • Values of closure time tested with the Platelet Function Analyzer equipment, for both cartridges of collagen/epinephrine and collagen/adenosine diphosphate below the upper limit of normal range at screening.

Main Exclusion Criteria:

  • Known hypersensitivity to ACT-246475 or drugs of the same class, or any excipients of the ACT-246475 formulation,
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed),
  • Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers,
  • Platelet count < 120 x10^9 L-1 at screening,
  • Previous exposure to ACT-246475,
  • Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1.0 mSv in a period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2.0 mSv in a period of 2 years prior to screening, etc. (add 1 year per 1 mSv),
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or during participation in a clinical study, in the period of 1 year prior to screening,
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Universitäts-Herzzentrum Bad Krozingen

    Bad Krozingen, 79189

  • Universitäts-Herzzentrum Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

Other trials in Germany

About this study

Official title: 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

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.

Being tested
ACT-246475

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-246475Drug

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

Study groups in NCT03593278
Study groupRoleWhat they receive
Treatment and observation periodExperimentalOn Day 1, the subjects will receive a single s.c. dose of 16 mg 14C-radiolabeled ACT-246475 in the fasted state. Subjects will be followed by an observation period of 3 days (72 h) during which blood, urine, and feces samples will be collected.
Receives: Drug: ACT-246475

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative excretion of total 14C-radioactivity in urine and feces

    Cumulative amount of total 14C-radioactivity excreted in urine and feces will be calculated by summing up the amount of total 14C-radioactivity of the samples excreted in each collection interval

    Measured: Up to 54 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start27 Jul 2018
  3. Primary completion5 Aug 2018
  4. Study completion5 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03593278
Sponsor's protocol ID
ID-076-104
Other IDs
2017-004622-15, 2017
Status last verified
Nov 2022
First submitted
10 Jul 2018
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACT-246475 in people with Healthy Subjects, run by Viatris Innovation GmbH at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative excretion of total 14C-radioactivity in urine and feces (time frame: Up to 54 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03593278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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