BAY2586116 Nasal Spray and OSA Severity

Flinders University

Status and phase: Completed; Phase 1

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: BAY2586116; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05527457

5468

Details and patient eligibility

About

This investigator-initiated study aims to determine the effects of BAY2586116 (a novel TASK channel blocker nasal spray) on sleep apnoea severity and the potential influence of route of breathing.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female participants aged 18 years or older at screening
• Must have completed Part A of the KOALA study (NCT04236440)
• Must be willing to sleep three nights in the sleep lab without OSA therapy (This includes continuous positive airway pressure therapy (CPAP) and/or a mandibular advancement device (MAD))
• Must be willing to refrain from drinking alcohol on the study days.
• Must be willing to limit consumption of tobacco to four cigarettes or one cigar a day and not smoke while at the sleep laboratory. This might be up to 12 hours.
• Must be willing to limit caffeinated beverage intake (coffee, tea, cola, and other soft drinks) to 400 mg / day or less of caffeine and not to be used within 4 hours of bedtime on study days.
• Contraceptive use required by men or women according to the methods of contraception for those participating in clinical studies

Exclusion criteria

• Any medications or herbal supplements that may interfere or be contraindicated with the study drug as determined by the investigator
• Severely impaired breathing within two days prior to randomization (e.g., acute nasal congestion during upper airway infection).
• known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
• Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (saline) nasal spray, taken before bedtime. Dosage is taken on one instance for one night only.

Treatment:

Drug: Placebo

BAY2586116 (oro-nasal breathing night)

Experimental group

Description:

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the oro-nasal breathing night.

Treatment:

Drug: BAY2586116

BAY2586116 (nasal breathing only night)

Experimental group

Description:

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night.

Treatment:

Drug: BAY2586116