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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593278
• Other study ID #: ID-076-104
• Secondary ID: 2017-004622-15
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2018
• Est. completion date: August 5, 2018

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study will also investigate how safe is ACT-246475 and how well it is tolerated when administered to healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 5, 2018
• Est. primary completion date: August 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Germany	Universitäts-Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Universitäts-Herzzentrum Freiburg	Freiburg
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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