insomia sleeplessness
Conditions
Interventions
None listed
Sponsors
Actelion Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Signed informed consent prior to any study-mandated procedure.;Male aged between 18 and 45 years (inclusive) at screening.;CYP2D6 extensive metabolizer (EM) genotype.;No clinically significant findings on the physical examination at screening.;Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening.;Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and heart rate (HR) 45-90 bpm (all inclusive), measured at screening on the leading arm after 5 minutes in the supine position.;12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening and meeting the following criteria: QTcB interval * 430 msec, QRS interval * 110 msec, and PR interval * 220 msec.;Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.;Negative results from urine drug screen at screening.;Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: History of cardiovascular disease (e.g., arrhythmia, congenital long QT syndrome).;History of seizures disorders.;Clinically significant findings at baseline assessments for pupillometry.;Any contraindication to desipramine or any tricyclic antidepressant (TCA).;Known hypersensitivity to desipramine, or any TCA, Ponceau 4R, or any other excipients of the drug formulations.;Treatment with any prescribed or OTC medications (including herbal medicines such as St John*s Wort) within 2 weeks prior to screening.;Treatment with another investigational drug within 3 months prior to screening or more than 4 times within the year prior to screening.;History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.;Excessive caffeine consumption (more than 800 mg per day) at screening .;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 drugs.;Smoking within 3 months prior to screening and inability to refrain from smoking during the course of study.;Loss of 250 mL or more of blood within 3 months prior to screening.;Positive hepatitis serology, except for vaccinated subjects, at screening.;Positive HIV serology at screening.;Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.;Legal incapacity or limited legal capacity at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables/outcomes: • Maximum concentration (Cmax) of desipramine • Area under the plasma concentration-time curve from zero to infinity (AUC0-*) of desipramine | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables/outcomes: • Maximum concentratie (Cmax) of the metabolite 2-OH desipramine • Area under the plasma concentration-time curve from zero to infinity (AUC0-*) of the metabolite 2-OH desipramine • Time to reach Cmax (tmax) of desipramine (and the metabolite 2-OH desipramine). • Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the quantificationlimit (AUC0 t) of desipramine (and the metabolite 2-OH desipramine). • The halflife (t*) of desipramine (and the metabolite 2-OH desipramine). • Maximum concentration (Cmax) of ACT 078573. • Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24) of ACT 078573. • Time to reach Cmax (tmax) of ACT 078573. Pharmacodynamic outcomes/variables: Eye Movements: • Saccadic peak velocity Adaptive tracking: • Adaptive tracking performance Body Sway Pupillometry: • Pupil / iris ratio Visual analog scale (VAS) Bond & Lader: • Alertness • Mood • Calmness | — |
Countries
Netherlands
Outcome results
None listed