Sleep ApneaPhase 1NCT01300455

Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)

A Phase 1 study testing Suvorexant in people with Sleep Apnea, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Sleep Apnea
What is being tested?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: No sites listed yet
Study dates: 19 Mar 2011to 11 Aug 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female participants of reproductive potential must demonstrate a serum β-human chorionic gonadotrophin (hCG) level consistent with the nongravid state at the pre-study (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the pre-study visit throughout the study.
Women who are postmenopausal without menses for at least 1 year and a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, and/or are status post hysterectomy, oophorectomy or tubal ligation may participate.
Participants with a Body Mass Index (BMI) ≤40 kg/m2 at the pre-study (screening) visit.
Participants have to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
Participants without clinically significant abnormality on electrocardiogram (ECG) performed at the pre-study (screening) visit and/or prior to administration of the initial dose of study drug.
Participants have an International Classification of Sleep Disorders diagnosis of OSA.

Show all 11Show fewer

Participants have confirmed mild or moderate OSA (defined as mild
OSA with AHI ≥5 and <15, and moderate OSA with AHI ≥15 and <30) based on the screening nighttime polysomnography (NPSG).
Participants have a usual bedtime between 20:00 (8:00 post meridiem [PM]) and 00:30 (12:30 ante meridiem [AM)] and is not subject to any other unusual changes in sleeping routine and sleeps for 4 hours or more per night.
Participants must complete a sleep history diary for at least 5 consecutive days and up to 21 days prior to the screening PSG visit.
Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; participants who have discontinued smoking or the use of nicotine/nicotine containing products for at least approximately 3 months may be enrolled in the study at the discretion of the investigator.

Who cannot join

Participants have used continuous positive airway pressure devise (CPAP) or a dental appliance within the preceding 7 days prior to screening NPSG Visit, or is required to use CPAP or a dental appliance during course of the study (7 days prior to the screening NPSG, throughout the study [including washout intervals between treatment periods], and until the poststudy visit).
Participants have other than OSA and evidence of another clinically significant, active pulmonary disorder such as bronchiectasis, emphysema, or asthma documented by history, physical examination, or chest x-ray.
Participant have either a history within the past 6 months prior to the prestudy visit or current evidence of an unstable or clinically significant cardiovascular disorder, including but not limited to acute coronary syndrome, unstable angina, congestive heart failure, cardiogenic syncope, cardiomyopathy, any symptomatic arrhythmia, orthostatic hypotension, or uncontrolled hypertension.
Participants have abnormal pre-randomization laboratory values other clinically significant, unexplained laboratory abnormality in the opinion of the investigator with alanine transaminase (ALT) >1.5 x the upper limit of normal (x ULN), aspartate transaminase (AST) >1.5 x ULN, total bilirubin >1.5 x ULN, or serum creatinine of >2 mg/dL.
Participants have a history or diagnosis of narcolepsy, cataplexy (familial or idiopathic), circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder, periodic limb movement (PLM) disorder, restless legs syndrome, or primary hypersomnia.
Participants have a screening PSG recording with oxygen (O2) saturation <80% for ≥5% of the total sleep time, and >10 PLM per hour associated with an arousal (periodic limb movement arousal index [PLMAI]).

Show all 24Show fewer

Participant is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. Participant who have had situational depression may be enrolled in the study at the discretion of the investigator.
Participant has lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; or, a psychiatric condition requiring treatment with a prohibited medication; or, other psychiatric condition that, in the investigator's opinion, would interfere with the participant's ability to participate in the study.
Participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab or ECG abnormality or other circumstances that might confound the results of the study, or interfere with the participant's participation for the full duration of the study.
Participant has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness within the last 10 years.
Participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Participants with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator.
Participant has a history of neoplastic disease except: 1. adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the study; 2. participants with other malignancies which have been successfully treated ≥10 years prior to the prestudy (screening) visit where, in the judgment of both the Investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the prestudy (screening) visit, or 3. participants, who, in the opinion of the Investigator, are highly unlikely to sustain a recurrence for the duration of the study.
Participant is a nursing mother.
Participant has a positive screening urine alcohol test or drug test.
Participant has a need for more than 3 toilet visits during the night.
Participant is taking, or plans to take, one or more of prohibited concomitant medication.
Participant consumes excessive amounts of alcohol (greater than 3 glasses of alcoholic beverages), excessive amounts of coffee, tea, cola, or other caffeinated beverages per day.
Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
Participant has a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
Participant is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years.
Participant works a night shift and is not able to avoid night shift work within 2 weeks before each treatment visit (or before the study start and during the study).
Participant has traveled across 3 or more time zones (transmeridian travel) in the last 1 week prior to study start.
Participant is at imminent risk of self-harm or harm to others
Any concern by the investigator regarding the safe participation of the participant in the study or for any other reason; the investigator considers the participant inappropriate for participation in the study.

About this study

Official title: A Study to Evaluate the Effects of MK-4305 in Patients With Obstructive Sleep Apnea

This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce a clinically significant increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.

Conditions: Sleep Apnea
Being tested: Suvorexant, Matching Placebo
Keywords: Insomnia, obstructive sleep apnea, orexin receptor antagonist
Medical subject headings: Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuvorexantDrug
Also called MK-4305, SCH 900433
40 mg tablets, orally once daily for 4 consecutive days in the evening
Matching PlaceboDrug
Placebo tablets, orally once daily for 4 consecutive days in the evening

Study groups in NCT01300455
Study group	Role	What they receive
Suvorexant (40 mg)	Experimental	In Period 1, suvorexant (40 mg tablets) administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening. Receives: Drug: Suvorexant; Drug: Matching Placebo
Placebo	Placebo comparator	In Period 1, placebo administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered once daily for 4 consecutive days in the evening. Receives: Drug: Suvorexant; Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 4
Number of Participants With an Adverse Event
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.
Measured: Up to 14 days after last dose
Number of Participants Who Discontinued 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.
Measured: Up to 13 days

Secondary outcomes (4)

Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.
Measured: Day 1 and Day 4
Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 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. Total sleep time is the total of all REM and non-REM sleep in a sleep episode.
Measured: Day 1 and Day 4
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. Sleep stages were determined by polysomnography.
Measured: Day 1 and Day 4
Mean AHI
Evaluation of the effect of multiple dose administration of suvorexant on
AHI as measured by polysomnography. The AHI is an overall index of 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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201111 Aug 2011

First posted21 Feb 2011 (estimated)
Study start19 Mar 2011
Primary completion11 Aug 2011
Study completion11 Aug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01300455
Sponsor's protocol ID: 4305-036
Status last verified: Aug 2018
First submitted: 17 Feb 2011
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Sun H, Palcza J, Card D, Gipson A, Rosenberg R, Kryger M, Lines C, Wagner JA, Troyer MD. Effects of Suvorexant, an Orexin Receptor Antagonist, on Respiration during Sleep In Patients with Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Jan;12(1):9-17. doi: 10.5664/jcsm.5382.
PubMed 26194728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effects of MK-4305 in Patients With Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT01300455
Acronym / sponsor ID: 4305-036
Conditions: Sleep Apnea
Keywords: Insomnia, obstructive sleep apnea, orexin receptor antagonist
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 19 Mar 2011 (actual)
Primary completion: 11 Aug 2011 (actual)
Study completion: 11 Aug 2011 (actual)
First posted: 21 Feb 2011 (estimated)
Results: Posted 29 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Suvorexant (40 mg)	Experimental	Drug: Suvorexant, Drug: Matching PlaceboIn Period 1, suvorexant (40 mg tablets) administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
Placebo	Placebo comparator	Drug: Suvorexant, Drug: Matching PlaceboIn Period 1, placebo administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered once daily for 4 consecutive days in the evening.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Female participants of reproductive potential must demonstrate a serum β-human chorionic gonadotrophin (hCG) level consistent with the nongravid state at the pre-study (screening) visit and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the pre-study visit throughout the study.
Women who are postmenopausal without menses for at least 1 year and a follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-study (screening) evaluation, and/or are status post hysterectomy, oophorectomy or tubal ligation may participate.
Participants with a Body Mass Index (BMI) ≤40 kg/m2 at the pre-study (screening) visit.
Participants have to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
Participants without clinically significant abnormality on electrocardiogram (ECG) performed at the pre-study (screening) visit and/or prior to administration of the initial dose of study drug.

Key exclusion criteria (24 listed)

Participants have used continuous positive airway pressure devise (CPAP) or a dental appliance within the preceding 7 days prior to screening NPSG Visit, or is required to use CPAP or a dental appliance during course of the study (7 days prior to the screening NPSG, throughout the study [including washout intervals between treatment periods], and until the poststudy visit).
Participants have other than OSA and evidence of another clinically significant, active pulmonary disorder such as bronchiectasis, emphysema, or asthma documented by history, physical examination, or chest x-ray.
Participant have either a history within the past 6 months prior to the prestudy visit or current evidence of an unstable or clinically significant cardiovascular disorder, including but not limited to acute coronary syndrome, unstable angina, congestive heart failure, cardiogenic syncope, cardiomyopathy, any symptomatic arrhythmia, orthostatic hypotension, or uncontrolled hypertension.
Participants have abnormal pre-randomization laboratory values other clinically significant, unexplained laboratory abnormality in the opinion of the investigator with alanine transaminase (ALT) >1.5 x the upper limit of normal (x ULN), aspartate transaminase (AST) >1.5 x ULN, total bilirubin >1.5 x ULN, or serum creatinine of >2 mg/dL.
Participants have a history or diagnosis of narcolepsy, cataplexy (familial or idiopathic), circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder, periodic limb movement (PLM) disorder, restless legs syndrome, or primary hypersomnia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SuvorexantAlso: MK-4305, SCH 90043340 mg tablets, orally once daily for 4 consecutive days in the evening	Drug	Placebo, Suvorexant (40 mg)
Matching PlaceboPlacebo tablets, orally once daily for 4 consecutive days in the evening	Drug	Placebo, Suvorexant (40 mg)

Primary outcome

Mean Apnea-Hypopnea Index (AHI)
Time frame: Day 4
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.
Number of Participants With an Adverse Event
Time frame: Up to 14 days after last dose
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.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 13 days
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.

4 secondary outcomes

Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time
Time frame: Day 1 and Day 4
Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%
Time frame: Day 1 and Day 4
Mean Arterial SaO2 for Different Sleep Stages
Time frame: Day 1 and Day 4
Mean AHI
Time frame: Day 1

Results and safety

Results posted to the registry on 29 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suvorexant (40 mg) Then Placebo	13	13
Placebo Then Suvorexant (40 mg)	13	13

Primary outcome: Mean Apnea-Hypopnea Index (AHI)

Time frame: Day 4. Least squares mean (95% Confidence Interval). Unit: Events per hour

Measure	Suvorexant (40 mg) n = 26	Placebo n = 25
Value	17.07 (13.30 to 20.84)	14.41 (10.61 to 18.22)

Suvorexant (40 mg) vs Placebo: Mean Difference (Final Values): 2.66 (90% CI 0.22 to 5.09), Difference of the Least Squares Means

Population analysed: Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.

Primary outcome: Number of Participants With an Adverse Event

Time frame: Up to 14 days after last dose. Number. Unit: participants

Measure	Suvorexant (40 mg) n = 26	Placebo n = 26
Value	8	4

Population analysed: All participants were included in the Safety Population.

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an AE

Time frame: Up to 13 days. Number. Unit: participants

Measure	Suvorexant (40 mg) n = 26	Placebo n = 26
Value	0	0

Population analysed: All participants were included in the Safety Population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 14 days after last dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suvorexant (40 mg)	0 of 26 (0%)	5 of 26 (19.2%)	Not reported
Placebo	0 of 26 (0%)	2 of 26 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26194728Sun H, Palcza J, Card D, Gipson A, Rosenberg R, Kryger M, Lines C, Wagner JA, Troyer MD. Effects of Suvorexant, an Orexin Receptor Antagonist, on Respiration during Sleep In Patients with Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Jan;12(1):9-17. doi: 10.5664/jcsm.5382.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Sleep Apnea

RecruitingObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Suvorexant in people with Sleep Apnea, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Apnea-Hypopnea Index (AHI) (time frame: Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01300455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.