JRCT ID: jRCT2031200413
Registered date:11/03/2021
A drug-drug interactions and food-effect study of S-600918 in healthy adult participants
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Refractory chronic cough |
Date of first enrollment | 11/03/2021 |
Target sample size | 42 |
Countries of recruitment | |
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) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Corporate Communications Department |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |
Scientific contact | |
Name | Tsutae Nagata |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |