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

A phase 1, randomized, 2-way cross over study to assess the effect of cyclosporine on the pharmacokinetics of S-600918, a 1-sequence crossover study to assess the effect of S-600918 on the pharmacokinetics of midazolam, and a randomized, 2-way cross over study to assess the food-effect of S-600918, in healthy adult participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200413

Enrollment

Registered

2021-03-11

Start date

2021-03-11

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

Refractory chronic cough

Interventions

Oral administration of S-600918 300 mg

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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)	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

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