First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy male adults

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.

Criteria

Inclusion Criteria:

• Signed informed consent

• Healthy on the basis of physical examination, electrocardiogram and laboratory tests.

• A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake

• Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.

• Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.

Exclusion Criteria:

• 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

• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions

• Any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations

• Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol