Clinical trial NCT02719197: First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders
Official title: Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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


Eligibility 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: From baseline to end of study (EOS) (up to Day 12)
measure: Changes from baseline in supine blood pressure
timeFrame: From baseline to EOS (up to Day 12)
measure: Changes from baseline in electrocardiogram (ECG) variables
timeFrame: From baseline to EOS (up to Day 12)
measure: Changes from baseline in pulse rate
timeFrame: From baseline to EOS (up to Day 12)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) following single oral ascending doses
timeFrame: From pre-dose on Day 1 to up to Day 12
measure: Time to reach Cmax (tmax) following single oral ascending doses
timeFrame: From pre-dose on Day 1 to up to Day 12
measure: Terminal half-life [t(1/2)] following single oral ascending doses
timeFrame: From pre-dose on Day 1 to up to Day 12
measure: Area under the plasma concentration-time curve (AUC) following single oral ascending doses
timeFrame: From pre-dose on Day 1 to up to Day 12
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigator Site
Study officials:
References: