A Phase 1 Study of S-637880 - Investigation of the effects of multiple doses, and the drug-drug interaction with midazolam -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225143

Enrollment

Registered

2020-03-27

Start date

2020-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult subjects

Interventions

investigational material(s) Generic name etc : S-637880 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adult Japanese or Caucasian, male or female subjects

Exclusion criteria

Exclusion criteria: Subjects who are considered ineligible for this study by the investigator or subinvestigator due to history of metabolic, endocrine, hepatic, renal, pulmonary, hematological, cardiovascular, gastrointestinal, urological, immune, neurological, or psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
safety Adverse events, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), 12-lead ECG, urinary sediment, visual acuity test, fundoscopy, Columbia-Suicide Severity Rating Scale (C-SSRS), and percutaneous arterial oxygen saturation.	—

Secondary

Measure	Time frame
pharmacokinetics Blood and urine samples are obtained for analysis of the plasma and urine concentration of S-637880 and the major metabolite of S-637880. Blood samples are obtained for analysis of the plasma concentration of midazolam. The following PK parameters are calculated based on the plasma concentration data of S-637880, S-637880 metabolite, and midazolam: Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal elimination half-life (t1/2,z), mean residence time (MRT), apparent total clearance (CL/F), apparent volume of distribution in the terminal elimination phase (Vz/F), ratio of Cmax of S-637880 metabolite to Cmax of unchanged drug (MRCmax), and ratio of AUC of S-637880 metabolite to AUC of unchanged drug (MRAUC). The following PK parameters are calculated based on the urine concentration data of S-637880 and S-637880 metabolite: Renal clearance (CLR) and fraction of dose excreted in urine (Feu).	—

Measure

Time frame

pharmacokinetics Blood and urine samples are obtained for analysis of the plasma and urine concentration of S-637880 and the major metabolite of S-637880. Blood samples are obtained for analysis of the plasma concentration of midazolam. The following PK parameters are calculated based on the plasma concentration data of S-637880, S-637880 metabolite, and midazolam: Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal elimination half-life (t1/2,z), mean residence time (MRT), apparent total clearance (CL/F), apparent volume of distribution in the terminal elimination phase (Vz/F), ratio of Cmax of S-637880 metabolite to Cmax of unchanged drug (MRCmax), and ratio of AUC of S-637880 metabolite to AUC of unchanged drug (MRAUC). The following PK parameters are calculated based on the urine concentration data of S-637880 and S-637880 metabolite: Renal clearance (CLR) and fraction of dose excreted in urine (Feu).

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026