Insomnia disorder MedDRA version: 20.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: -
Product Code: ACT-541468
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: -
Current Sponsor code: ACT-541468
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent prior to any study-mandated procedure; - Male or female aged =65 years; - Body mass index (BMI): 18.5 = BMI (kg/m2) =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: - Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy; - Self-reported usual daytime napping = 1 hour per day, and = 3 days per week; - Caffeine consumption = 600 mg per day; - Shift work within 2 weeks prior to the screening visit, or planned shift work during study; - Travel = 3 time zones within 1 week prior to the screening visit, or planned travel = 3 time zones during study; - Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator; - AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN - Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min). - History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments; - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of the study is to evaluate the dose-response of ACT-541468 on Latency to Persistent Sleep (LPS) on the first two days of each treatment period.;Primary end point(s): Change of WASO (Wake After Sleep Onset) from baseline to Days 1 & 2 as determined by Polysomnography (PSG).;Timepoint(s) of evaluation of this end point: From Baseline to Days 1&2 ;Main Objective: The primary objective of the study is to evaluate the dose-response of ACT-541468 on the change of Wake After Sleep Onset (WASO) assessed by polysomnography (PSG) on the first two days of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline to Days 1&2 in mean LPS (Latency to Persistent Sleep).;Timepoint(s) of evaluation of this end point: From Baseline to Days 1&2. | — |
Countries
Germany, United States
Contacts
Public ContactClinical Trial Disclosure Desk
Actelion Pharmaceuticals Ltd
Outcome results
None listed