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

NCT03593278 | Completed Phase 1 FDA Drug

• 2 other identifiers: ID-076-1042017-004622-15
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (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

  Up to 54 days

Study Arms (1)

Treatment and observation period

EXPERIMENTAL

On 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.

Drug: ACT-246475

Interventions

ACT-246475 DRUG

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

Treatment and observation period

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (3)

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, 67063, Germany

Location

MeSH Terms

Interventions

selatogrel

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: July 27, 2018
• Primary Completion: August 5, 2018
• Study Completion: August 5, 2018
• Last Updated: July 3, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)