A drug-drug interactions and food-effect study of S-600918 in healthy adult participants

JRCT ID: jRCT2031200413

Registered date:11/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Refractory chronic cough
• Date of first enrollment: 11/03/2021
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Oral administration of S-600918 300 mg

Outcome(s)

• Primary Outcome: Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal elimination half-life (t1/2,z), and terminal elimination rate constant (lambdaz), mean residence time (MRT), apparent total clearance (CL/F), and apparent volume of distribution in the terminal elimination phase (Vz/F)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

-Apparently healthy as determined by the investigator or subinvestigator based on medical assessment.
-Weight within the range 50 kg (inclusive) to 85 kg (exclusive), and body mass index (BMI) within the range 18.5 kg/m2 (inclusive) to 25.0 kg/m2 (inclusive).
-Capable of giving the signed ICF as described in this protocol which includes compliance with the requirements and deadlines listed in the ICF and in this protocol.

Exclude criteria

-History or presence of significantly disorders that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or donfound data interaption.
-Exposure to more than 4 study drugs within 12 months prior to the first dose of study intervention.
-Previous administration of S-600918.
-Ineligibility for the study as considered by the investigator or subinvestigator.

Related Information

• Primary Sponsor: Nagata Tsutae