Clinical trial NCT02702648: First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders
Official title: Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: healthy subjects
first-in-man
safety
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
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 adults


Eligibility 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to end of study (up to Day 11)
measure: Changes from baseline in vital signs
timeFrame: Up to end of study (up to Day 11)
measure: Changes from baseline in ECG variables
timeFrame: Up to end of study (up to day 11)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) following single ascending doses
timeFrame: From pre-dose on Day 1 to 96 hours post dose
measure: Time to reach Cmax (tmax) following single ascending doses
timeFrame: From pre-dose on Day 1 to 96 hours post dose
measure: Terminal half-life [t(1/2)] following single ascending doses
timeFrame: From pre-dose on Day 1 to 96 hours post dose
measure: Area under the plasma concentration-time curve (AUC) following single ascending doses
timeFrame: From pre-dose on Day 1 to 96 hours post dose
measure: Maximum plasma concentration (Cmax) following multiple ascending doses
timeFrame: Up to 96 hours following the last dose administration on Day 4
measure: Time to reach Cmax (tmax) following multiple ascending doses
timeFrame: Up to 96 hours following the last dose administration on Day 4
measure: Terminal half-life [t(1/2)] following multiple ascending doses
timeFrame: Up to 96 hours following the last dose administration on Day 4
measure: Area under the plasma concentration-time curve during a dosing interval (AUCtau)
timeFrame: Day 1 and Day 4
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigator Site
Study officials:
affiliation: Actelion
name: Karine Litherland, PhD
role: STUDY_DIRECTOR
References: