A Phase 1 Study of S-892216 (COVID-19)

JRCT ID: jRCT2031230082

Registered date:20/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 01/05/2023
• Target sample size: 264
• Study type: Interventional
• Intervention(s): Oral administration of S-892216 or placebo

Outcome(s)

Primary Outcome

Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG, holter ECG, Columbia-Suicide Severity Rating Scale (C-SSRS), Patient Health Questionnaire-9 (PHQ-9) (Part 1, Part 3, and Part 5)
S-892216 : Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, gammaz, MRT, CL/F, Vz/F (Part 2, Part 4)
S-892216 N-oxide : Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z,gammaz, MRT, MRCmax, MRAUC0-inf (Part 2, Part 4)
Itraconazole, Carbamazepine : Cmax, Tmax, AUC0-tau (Part 4)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Common in all parts
-Apparently healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECG at screening and on admission. Or, determined to be eligible for participation by the investigator or subinvestigator in consideration of the safety in case for participants with clinical laboratory test results beyond the upper limit or below the lower limit of the reference range of the study site.
-Male and female
-Capable of giving signed informed consent as described in this protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Only for part 1, 2, and 4
-Participant must be 20 to 55 years of age inclusive, at the time of signing the ICF.
-A person with Japanese parents.
-Body Mass Index (BMI) >= 18.5 and =< 30.0.

Only for Part 3
-Participant must be 20 to 55 years of age inclusive, at the time of signing the ICF.
-In Cohort H and J, a person with Japanese parents.
-In Cohort K, a healthy adult White with White parents (regardless of nationality of the parents), who lives in Japan. Must possess Japanese citizenship, a special permanent resident certificate, or a residence card.
-Body Mass Index (BMI) >= 18.5 and =< 30.0.

Only for Part 5
-Participant must be 65 years of age and older at the time of signing the ICF.
-A person with Japanese parents.
-Body Mass Index (BMI) >= 18.5 and =< 30.0. Body weight >= 40 kg.

Exclude criteria

Common in all parts
-History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may significantly alter the absorption, metabolism, or elimination of drugs; determined to constitute a risk when administering the study intervention or to interfere with the interpretation of data.
-In C-SSRS examined at screeing or on admission, 'Yes' to questions regarding suicidal ideation 1 to 5, or to questions regarding unintended self-injury behavior out of suicidal behavior, or judged as having risks for suicide in the opinion of the investigator.
-At screeing or on admission, The total score of 10 points or more in PHQ-9.

Related Information

• Primary Sponsor: Gomez Juan Carlos
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development