This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants \<65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days
one tablet matching suvorexant, orally, once daily, for 4 consecutive days
Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Time frame: Day 4 of each period
Number of Participants With Adverse Events
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Time frame: Up to 14 days after last dose
Number of Participants Discontinued From Study Drug Due to an AE
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Time frame: Up to 15 days
Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%
Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.
Time frame: Day 1 and Day 4 of each period
Mean Apnea/Hypopnea Index (AHI)
Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to \<15/hr and moderate OSA = 15 to \<30/hr.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 and Day 4 of each period
Mean Arterial SaO2 for Different Sleep Stages
Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.
Time frame: Day 1 and Day 4 of each period
Mean Arterial SaO2 During Total Sleep Time
Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Time frame: Day 1 of each period