The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil. The study will also investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with remifentanil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
18
Ampakine CX1739 - 300 mg
CX1739 - 600 mg
CX1739 - 900 mg
Duke Clinical Research Unit
Durham, North Carolina, United States
Respiratory depression
Respiratory rate, tidal volume, minute volume as determined by plethysmography
Time frame: Sequence #1 - 30 minutes
Pain tolerance threshold
Analgesia assessed by pain tolerance threshold to 5, 250, and 2000 Hertz sine-wave electrical stimulation using the quantitative sensory testing device - Neurometer
Time frame: Sequence #2 - 20 minutes
Maintenance of sedation
Bispectral index (BIS) measure of sedation
Time frame: Sequence #1 - 30 minutes
The number of patients that experience an adverse drug reaction upon ingestion of CX1739 when used alone or in conjunction with remifentanil
Vital signs, including noninvasive blood pressure, heart rate, RR, end-tidal carbon dioxide, pulse oximetry saturation, and temperature * Electrocardiograms * Focused physical examinations * Adverse events
Time frame: up to 5 weeks
Change in pupil size
Pupil size will be assessed intermittently with a noninvasive pupillometer incorporated into a pair of glasses placed on the subject's head
Time frame: Sequence #2 - 20 minutes
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Placebo to 300 mg CX1739