First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

• Status: Completed
• Trial end date: 2017-03-06
• Target enrollment: 0
• Participant gender: All

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 adults

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

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.

Criteria

Key inclusion Criteria:

• Signed informed consent

• Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests

• Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)

• Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1

• Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)

• Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively

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