Obstructive Sleep Apnea Clinical Trial
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. 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
| Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
| Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
| Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
| Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
| Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
| Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
| Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
| Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
| Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
| Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
| Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
| Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
| Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
| Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |