Trial · NCT02291783
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Adverse Events, as a measure of safety and tolerability | From signing of informed consent up to 30 days after the final visit | AE reports include a description of the AE, date and time of onset and resolution, intensity, and relationship to IMP. |
| Primary | Changes in Safety Lab parameters as a measure of safety and tolerability | Screening, Day-1, at select dosing days, and at 5 to 7 days post dose for single doseand 15 to 17 days post first dose in multiple dosing. | Hematology, clinical chemistry, urinalysis |
| Primary | Changes in vital signs as a measure of safety and tolerability | Screening, Day-1, at select dosing days and at 5 to 7 days post dose for single dose, and 15 to 17 days post first dose in multiple dosing. | Pulse rate,body temperature,blood pressure, and orthostatic changes. |
| Primary | Changes in 12-lead electrocardiograms as a measure of safety and tolerability | Screening, pre-dose, at select dosing days and at 5 to 7 days post dose for single dose,and 15 to 17 days post first dose in multiple dosing. | Change in ECG parameters |
| Secondary | Pharmacokinetic measures in plasma as measured by Peak plasma concentration (Cmax) | Pre-dose, multiple time points to 24h, at select dosing days, and 5 to 7 days post dosefor single dose,and 15 to 17 days post first dose in multiple dosing. | Peak plasma concentration (Cmax), time at occurrence of Cmax (tmax), Area under the plasma concentration versus time curve (AUC) 0-t, 0- infinity, percent of AUC 0-infinity, Cmax normalized by dose, AUC 0-t normalized for dose. |
| Secondary | Pharmacokinetic measures in cerebro spinal fluid (CSF) in young males as measured by max observed CSF (Cmax CSF) | Part 1 - 1h, 2h,3h post dose | Maximum observed CSF concentration (Cmax CSF), area under the CSF concentration versus time |
| Secondary | Pharmacokinetic measures to assess the food effect as measured by ANOVA | Pre-dose, multiple time points to 24h, and at 12h, 24h and 5 to 7 days post dose. | Food effect analysis will be based on analysis of variance (ANOVA) for treatment differences. |
| Secondary | Pharmacodynamic response as measured by pupillometry | Multiple time points Day1 to 6h post dose Part 1 only. | Changes in average pupil diameter as measured in 3 different conditions of lux. |
| Secondary | Pharmacokinetic measures in urine in young males and elderly male and female subjects as measured by amount of urine excreted at collection intervals | Pre-dose,multiple 4h collection intervals to 24h post dose on select dosing days to Day 10 for multiple dosing. | Amount excreted in urine at each collection interval (Ae1-t2) all parts. Cumulative amount excreted to 12h and 24h (Ae0-t) depending on Part. Cumulative urine excreted of unchanged drug to 24h (Fe%) and to 12h depending on Part. Volume of urine collected during each collection interval (Vur), and renal clearance (CLr) all parts |
| Secondary | Pharmacodynamic response as measured by Bond and Lader visual analogue scale | Day 1 at multiple timepoints to 24h post dose. | Changes in 3 factor scores (Alertness, Contentedness and Calmness) which will be derived from the individual VAS scores |
| Secondary | Pharmacodynamic response as measured by changes in qEEG and Event Related Potentials (ERP) | Screening, Day-1, Day 4, Day 9 multiple dosing regimen only | qEEg and ERP (P50 sensory gating, Mismatch Negativity and P300) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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