Sleep Apnea Syndrome
Conditions
Interventions
investigational material(s)
Generic name etc : S-600918
INN of investigational material : sivopixant
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration
Sponsors
SHIONOGI & CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: - Participants diagnosed with sleep apnea syndrome or suspected sleep apnea based on the International Classification of Sleep Disorders, Third Edition (ICSD-3).
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: - Participants with a clinically significant active respiratory disease. - Participants with obvious morphological abnormalities of the upper respiratory tract, micrognathia, or developmental failure of the mandible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy To assess the improvement effect on apnea and hypopnea, compared to placebo, after 7 days of S-600918 300 mg administration, in participants with sleep apnea syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics -To assess the symptom improvement, after 7 days of S-600918 300 mg administration, in participants with sleep apnea syndrome. - To assess the PK profiles of S-600918 and the metabolite of S-600918 (acyl glucuronide). - To assess the safety and tolerability of S-600918, after 7 days of S-600918 300 mg administration, in participants with sleep apnea syndrome. | — |
Countries
Japan
Outcome results
None listed