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

ID-076-104

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.

2018-07-27

2018-08-05

2018-08-05

Completed

Early phase I

6

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2022-11-16