Obstructive Sleep ApneaPhase 1NCT04872387
A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose
A Phase 1 study testing BAY2586116 in people with Obstructive Sleep Apnea, run by Bayer at 1 site in Japan.
Trial summary
BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- BAY2586116
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 11 May 2021to 26 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation (including medical and surgical history, physical examination, laboratory tests, ECG, vital signs).
- Participant must be 20 to 45 years of age inclusive, at the time of signing the ICF.
- BMI above or equal 18.0 and below or equal 29.9 kg/m² at screening.
- Male.
- Japanese.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A sexually active man who has not been surgically sterilized has to agree not to act as sperm donor for the time period between signing of the ICF and 90 days after the last administration of study intervention.
Who cannot join
- A history of relevant diseases of vital organs, of the CNS (central nervous system) or other organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Given the nasal administration route, these diseases include (but are not limited to) any symptomatic and/or a history of relevant diseases of the ear, nose, and throat area (e.g. acute allergic rhinitis, acute infectious rhinitis, acute or chronical sinusitis, infection of the upper respiratory tract, symptomatic deviation of the nasal septum or a different relevant impairment of nasal breathing, history of any surgery of the ear, nose, and throat area [exception: sole history of adenectomy and/or tonsillectomy and/or paracentesis >1 year prior to 1st administration of study intervention], anatomical abnormalities of the ear, nose, and throat area [e.g. surgical corrected or uncorrected cheilognathopalatoschisis]).
- Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
- Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
- Participants with thyroid disorders as evidenced by assessment of thyroid stimulating hormone levels outside the normal reference range at screening.
Show all 12Show fewer
- Personal or familial history of genetically muscular diseases.
- History of autoimmune disease.
- Known hypersensitivity to the study interventions (active substances or excipients of the preparations).
- Known severe allergies, e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract, allergic asthma, allergies requiring therapy with corticosteroids, urticarial, or significant non-allergic drug reactions.
- History of known or suspected malignant tumors.
- Tendency for vasovagal reactions (e.g. after venipuncture) or history of syncope.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics After Single and Multiple Nasal Doses of BAY 2586116 in Japanese Healthy Male Participants
BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.
This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants.
Read more
The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray.
The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants' health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants' health again.
The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as "adverse events" while they are in the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- BAY2586116, Placebo
- Keywords
- Obstructive sleep apnea, Phase I study, Japanese healthy volunteer study
- 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.
BAY2586116Drug
Nasal administration
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| BAY2586116 Dose step 1 and Placebo | Experimental | Each participant of Dose step 1 will receive a single dose of BAY2586116 or placebo.
In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). Receives: Drug: BAY2586116; Drug: Placebo |
| BAY2586116 Dose step 2 and Placebo | Experimental | Each participant of Dose step 2 will receive a single dose of BAY2586116 or placebo.
In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). Receives: Drug: BAY2586116; Drug: Placebo |
| BAY2586116 Dose step 3 and Placebo | Experimental | Each participant of Dose step 3 will receive single and multiple doses of BAY2586116 or placebo administered once daily (OD) for 5 consecutive days.
In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). Receives: Drug: BAY2586116; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: From first administration up to 8 days after last dose (follow-up visit)
Secondary outcomes (8)
Cmax of BAY2586116
Cmax: maximum observed drug concentration in measured matrix after single dose administration.
Measured: Day 1
Cmax/D of BAY2586116
Cmax/d: Cmax divided by dose.
Measured: Day 1
AUC of BAY2586116
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose.
Measured: Day 1
AUC/D of BAY2586116
AUC/D: AUC divided by dose.
Measured: Day 1
Cmax,md of BAY2586116
Only for Dose step 3.
Measured: Day 5
Cmax,md/D of BAY2586116
Only for Dose step 3.
Measured: Day 5
AUCτ,md of BAY2586116
Only for Dose step 3. AUCτ,md: AUC during any planned dose interval after multiple dose.
Measured: Day 5
AUCτ,md/D of BAY2586116
Only for Dose step 3. AUCτ,md/D: AUCτ,md divided by dose.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start11 May 2021
- Primary completion4 Aug 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872387
- Sponsor's protocol ID
- 20906
- Status last verified
- Feb 2023
- First submitted
- 30 Apr 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Single-blind, Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics After Single and Multiple Nasal Doses of BAY 2586116 in Japanese Healthy Male Participants
- ClinicalTrials.gov ID
- NCT04872387
- Acronym / sponsor ID
- 20906
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Phase I study, Japanese healthy volunteer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.
This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants.
The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray.
The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants' health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants' health again.
The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as "adverse events" while they are in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAY2586116 Dose step 1 and Placebo | Experimental | Drug: BAY2586116, Drug: PlaceboEach participant of Dose step 1 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
| BAY2586116 Dose step 2 and Placebo | Experimental | Drug: BAY2586116, Drug: PlaceboEach participant of Dose step 2 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
| BAY2586116 Dose step 3 and Placebo | Experimental | Drug: BAY2586116, Drug: PlaceboEach participant of Dose step 3 will receive single and multiple doses of BAY2586116 or placebo administered once daily (OD) for 5 consecutive days. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who are overtly healthy as determined by medical evaluation (including medical and surgical history, physical examination, laboratory tests, ECG, vital signs).
- Participant must be 20 to 45 years of age inclusive, at the time of signing the ICF.
- BMI above or equal 18.0 and below or equal 29.9 kg/m² at screening.
- Male.
- Japanese.
Key exclusion criteria (12 listed)
- A history of relevant diseases of vital organs, of the CNS (central nervous system) or other organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention will not be normal.
- Given the nasal administration route, these diseases include (but are not limited to) any symptomatic and/or a history of relevant diseases of the ear, nose, and throat area (e.g. acute allergic rhinitis, acute infectious rhinitis, acute or chronical sinusitis, infection of the upper respiratory tract, symptomatic deviation of the nasal septum or a different relevant impairment of nasal breathing, history of any surgery of the ear, nose, and throat area [exception: sole history of adenectomy and/or tonsillectomy and/or paracentesis >1 year prior to 1st administration of study intervention], anatomical abnormalities of the ear, nose, and throat area [e.g. surgical corrected or uncorrected cheilognathopalatoschisis]).
- Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
- Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
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 |
|---|---|---|
| BAY2586116Nasal administration | Drug | BAY2586116 Dose step 1 and Placebo, BAY2586116 Dose step 2 and Placebo, BAY2586116 Dose step 3 and Placebo |
| PlaceboMatching placebo | Drug | BAY2586116 Dose step 1 and Placebo, BAY2586116 Dose step 2 and Placebo, BAY2586116 Dose step 3 and Placebo |
Primary outcome
Number of participants with adverse events
Time frame: From first administration up to 8 days after last dose (follow-up visit)
8 secondary outcomes
Cmax of BAY2586116
Time frame: Day 1
Cmax/D of BAY2586116
Time frame: Day 1
AUC of BAY2586116
Time frame: Day 1
AUC/D of BAY2586116
Time frame: Day 1
Cmax,md of BAY2586116
Time frame: Day 5
Cmax,md/D of BAY2586116
Time frame: Day 5
AUCτ,md of BAY2586116
Time frame: Day 5
AUCτ,md/D of BAY2586116
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2586116 in people with Obstructive Sleep Apnea, run by Bayer at 1 site in Japan.
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 7 inclusion and 12 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (time frame: From first administration up to 8 days after last dose (follow-up visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2023.