Obstructive Sleep Apnea (OSA)Phase 1NCT03882801
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
A Phase 1 study testing Gefapixant in people with Obstructive Sleep Apnea (OSA), run by Merck Sharp & Dohme LLC at 5 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Gefapixant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 Apr 2019to 22 Oct 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- International Classification of Sleep Disorders (ICSD-3) diagnosis of OSA, based on investigator's assessment of the obstructive sleep apnea (OSA) history and diagnostic interview which must include: Documented sleep study in the past that confirmed the OSA diagnosis without significant prior medical intervention.
- Apnea-Hypopnea Index (AHI) ≥ 20 events/hour at screening.
- No use of a positive airway pressure (PAP) device within the preceding 1 month or a dental appliance within the preceding 7 days prior to screening and is not allowed to use PAP or a dental appliance throughout the study (including washout intervals between treatment periods) and until the post-study visit.
- A baseline oxygen saturation via pulse oximetry (SpO2) ≥ 94% at screening to ensure that carotid body response to hyperoxia is not impaired.
- A body mass index (BMI) ≤ 35 kg/m^2 at the pre-study (Screening 1) visit.
- Judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests.
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- No clinically significant abnormality on electrocardiogram (ECG)
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using an acceptable contraceptive method.
- A WOCBP must have a negative highly sensitive pregnancy test (urine as required by local regulations) within 72 hours before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- A consistent sleep-wake schedule that is not subject to any other unusual changes in sleeping routine (i.e., bedtimes and wake times do not vary more than 1-2 hours except on rare occasions).
- Able to maintain sleep for at least 4 consecutive hours based on self-report.
Who cannot join
- Other than OSA, has evidence of another clinically significant, active pulmonary disorder such as bronchiectasis, emphysema, or asthma documented by history, physical examination, or chest x-ray.
- A history within the past 6 months prior to the pre-study 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, uncontrolled hypertension, chronic kidney disease, kidney transplant
- Abnormal pre-randomization laboratory values for alanine transaminase > 1.5 x the upper limit of normal (x ULN), aspartate transaminase > 1.5 x ULN, direct bilirubin > 1.5 x ULN, serum creatinine of > 2 mg/dL
- A history or diagnosis of any of the following conditions, in the opinion of the investigator: narcolepsy (with or without cataplexy) or Idiopathic hypersomnia, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement (REM) behavior disorder, periodic limb movement (PLM) disorder, restless legs syndrome, chronic insomnia
- A WOCBP who has a positive urine or serum pregnancy test within 24 hours before the baseline 1 of study intervention.
- A history of clinically significant or poorly-controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
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- Mentally or legally incapacitated, or has significant emotional problems at the time of pre-study screening
- 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.
- 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.
- A history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or non-prescription drugs or food.
- A history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs.
- Positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- A history of cancer (malignancy) with some exceptions including adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or; and other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, in the opinion of the investigator and with agreement of the Sponsor (e.g., malignancies that have been successfully treated ≥ 10 years prior to the pre-study [screening] visit).
- An estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 based on the Cockcroft-Gault (CG) Equation.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Neurotrials Research, Inc. ( Site 0001)
Atlanta, Georgia, 30342
MD Clinical ( Site 0004)
Hallandale, Florida, 33009
Research Centers of America, LLC ( Site 0002)
Hollywood, Florida, 33024
Clinilabs, Inc. ( Site 0005)
New York, New York, 10019
About this study
Official title: A Randomized Double Blind Clinical Trial to Evaluate the Effects of MK-7264 in Participants With Obstructive Sleep Apnea
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA). The primary hypothesis is that multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe OSA reduces the Apnea Hypopnea Index (AHI) relative to placebo.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Gefapixant, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefapixantDrug
Also called MK-7264
In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS.
PlaceboDrug
In Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Placebo -> Gefapixant | Experimental | In Period 1, participants receive a single oral dose of placebo matching gefapixant (MK-7264) every night at bedtime (QHS), for 7 days. In Period 2, participants receive a single oral dose of gefapixant (MK-7264) QHS, for 7 days. The two 7-day dosing periods are separated by a 7-day washout period. Receives: Drug: Gefapixant; Drug: Placebo |
| Sequence 2: Gefapixant -> Placebo | Experimental | In Period 1, participants receive a single oral dose of gefapixant (MK-7264) QHS for 7 days. In Period 2, participants receive a single oral dose of placebo matching gefapixant (MK-7264) QHS, for 7 days. The two 7-day dosing periods are separated by a 7-day washout period. Receives: Drug: Gefapixant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)
The apnea-hypopnea index (AHI) is the sum of the apnea and hypopnea indices for each participant. The apnea index for each participant is calculated as the number of apneas divided by the total sleep time. The hypopnea index for each participant is calculated as the number of hypopneas divided by the total sleep time. These measurements are collected from polysonagraphs (PSGs), which are diagnostic sleep studies that collect electroencephalogram (EEG), electrooculograph (EOG), electromyogram (EMG), electrocardiogram (ECG), airflow, respiratory effort, oximetry, and sleep position data. Baseline AHI measurements in each period are obtained on Day -1. Individual AHI fold-change from baseline in each treatment period are calculated as the ratio of on-treatment AHI to baseline AHI.
Measured: Day-1 at Baseline and Day 7 of each treatment period
Secondary outcomes (2)
Number of Participants Who Experienced an Adverse Event (AE) During the Study
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.
Measured: Up to 14 days after last dose of study drug (Up to 35 days)
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, is also an AE.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start10 Apr 2019
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
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 Obstructive Sleep Apnea (OSA)Studies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882801
- Sponsor's protocol ID
- 7264-039
- Other IDs
- 2018-004099-37, MK-7264-039, 2018
- Status last verified
- Oct 2024
- First submitted
- 19 Mar 2019
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Robbins JA, Sands S, Maganti L, Crumley T, Fox-Bosetti S, Hussain A, Schwartz H, Safirstein B, Ahmad M, Dragone L, Nussbaum J, Kushida C, Iwamoto M, Stoch SA. Gefapixant as a P2X3 receptor antagonist treatment for obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2024 Dec 1;20(12):1905-1913. doi: 10.5664/jcsm.11272.
PubMed 39069967
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Clinical Trial to Evaluate the Effects of MK-7264 in Participants With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03882801
- Acronym / sponsor ID
- 7264-039
- Conditions
- Obstructive Sleep Apnea (OSA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA). The primary hypothesis is that multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe OSA reduces the Apnea Hypopnea Index (AHI) relative to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Placebo -> Gefapixant | Experimental | Drug: Gefapixant, Drug: PlaceboIn Period 1, participants receive a single oral dose of placebo matching gefapixant (MK-7264) every night at bedtime (QHS), for 7 days. In Period 2, participants receive a single oral dose of gefapixant (MK-7264) QHS, for 7 days. The two 7-day dosing periods are separated by a 7-day washout period. |
| Sequence 2: Gefapixant -> Placebo | Experimental | Drug: Gefapixant, Drug: PlaceboIn Period 1, participants receive a single oral dose of gefapixant (MK-7264) QHS for 7 days. In Period 2, participants receive a single oral dose of placebo matching gefapixant (MK-7264) QHS, for 7 days. The two 7-day dosing periods are separated by a 7-day washout period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- International Classification of Sleep Disorders (ICSD-3) diagnosis of OSA, based on investigator's assessment of the obstructive sleep apnea (OSA) history and diagnostic interview which must include: Documented sleep study in the past that confirmed the OSA diagnosis without significant prior medical intervention.
- Apnea-Hypopnea Index (AHI) ≥ 20 events/hour at screening.
- No use of a positive airway pressure (PAP) device within the preceding 1 month or a dental appliance within the preceding 7 days prior to screening and is not allowed to use PAP or a dental appliance throughout the study (including washout intervals between treatment periods) and until the post-study visit.
- A baseline oxygen saturation via pulse oximetry (SpO2) ≥ 94% at screening to ensure that carotid body response to hyperoxia is not impaired.
- A body mass index (BMI) ≤ 35 kg/m^2 at the pre-study (Screening 1) visit.
Key exclusion criteria (14 listed)
- Other than OSA, has evidence of another clinically significant, active pulmonary disorder such as bronchiectasis, emphysema, or asthma documented by history, physical examination, or chest x-ray.
- A history within the past 6 months prior to the pre-study 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, uncontrolled hypertension, chronic kidney disease, kidney transplant
- Abnormal pre-randomization laboratory values for alanine transaminase > 1.5 x the upper limit of normal (x ULN), aspartate transaminase > 1.5 x ULN, direct bilirubin > 1.5 x ULN, serum creatinine of > 2 mg/dL
- A history or diagnosis of any of the following conditions, in the opinion of the investigator: narcolepsy (with or without cataplexy) or Idiopathic hypersomnia, circadian rhythm sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement (REM) behavior disorder, periodic limb movement (PLM) disorder, restless legs syndrome, chronic insomnia
- A WOCBP who has a positive urine or serum pregnancy test within 24 hours before the baseline 1 of study intervention.
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 |
|---|---|---|
| GefapixantAlso: MK-7264In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS. | Drug | Sequence 1: Placebo -> Gefapixant, Sequence 2: Gefapixant -> Placebo |
| PlaceboIn Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS. | Drug | Sequence 1: Placebo -> Gefapixant, Sequence 2: Gefapixant -> Placebo |
Primary outcome
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG)
Time frame: Day-1 at Baseline and Day 7 of each treatment period
The apnea-hypopnea index (AHI) is the sum of the apnea and hypopnea indices for each participant. The apnea index for each participant is calculated as the number of apneas divided by the total sleep time. The hypopnea index for each participant is calculated as the number of hypopneas divided by the total sleep time. These measurements are collected from polysonagraphs (PSGs), which are diagnostic sleep studies that collect electroencephalogram (EEG), electrooculograph (EOG), electromyogram (EMG), electrocardiogram (ECG), airflow, respiratory effort, oximetry, and sleep position data. Baseline AHI measurements in each period are obtained on Day -1. Individual AHI fold-change from baseline in each treatment period are calculated as the ratio of on-treatment AHI to baseline AHI.
2 secondary outcomes
Number of Participants Who Experienced an Adverse Event (AE) During the Study
Time frame: Up to 14 days after last dose of study drug (Up to 35 days)
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39069967Robbins JA, Sands S, Maganti L, Crumley T, Fox-Bosetti S, Hussain A, Schwartz H, Safirstein B, Ahmad M, Dragone L, Nussbaum J, Kushida C, Iwamoto M, Stoch SA. Gefapixant as a P2X3 receptor antagonist treatment for obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2024 Dec 1;20(12):1905-1913. doi: 10.5664/jcsm.11272.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefapixant in people with Obstructive Sleep Apnea (OSA), run by Merck Sharp & Dohme LLC at 5 sites in 2 countries.
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 14 inclusion and 14 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 19 Nov 2020). 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?
Apnea-Hypopnea Index (AHI) Change From Baseline as Calculated From Polysonagraphy (PSG) (time frame: Day-1 at Baseline and Day 7 of each treatment period). 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 NCT03882801, 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 4 Nov 2024.