Thorough QT/QTc Study of S-600918 in Healthy Adult Participants

An Open-label Study to Assess the Safety and Tolerability of a Single Dose of S-600918 (Part 1) and a Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover, Thorough QT/QTc Study of S-600918 (Part 2) in Healthy Adult Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225293

Enrollment

Registered

2020-07-27

Start date

2020-07-29

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 subjects

Interventions

investigational material(s) Generic name etc : S-600918 INN of investigational material : sivopixant Therapeutic category code : 222 Antitussives Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy subjects

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
safety [Part 1] - The number and proportion of clinical and laboratory adverse events (AEs) in study participants exposed to a single 1000-mg dose of S-600918 [Part 2] - Change from baseline in QTcF (Delta QTcF), Placebo-corrected Delta QTcF (Double-Delta QTcF)	—

Secondary

Measure	Time frame
pharmacokinetics safety [Part 1] - S-600918: maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-time (t1/2,z), terminal elimination rate constant (lambda z), mean residence time (MRT), apparent total clearance (CL/F), apparent volume of distribution in the terminal elimination phase (Vz/F) - S-600918 acyl glucuronide: Cmax, Tmax, AUC, t1/2,z, lambda z, metabolic ratio of Cmax for metabolite to unchanged drug (MRCmax), metabolic ratio of AUC for metabolite to unchanged drug (MRAUC) [Part 2] - Change from baseline in HR, PR, QT, and QRS (Delta HR, Delta PR, Delta QT, and Delta QRS) - Placebo-corrected Delta HR, Delta PR, Delta QT, Delta QTcF, and Delta QRS (Double-Delta HR, Double-Delta PR, Double-Delta QT, Double-Delta QTcF and Double-Delta QRS) - Categorical outliers for HR, QTcF, PR, and QRS - Frequency of treatment-emergent changes for T-wave morphology and U-wave presence - S-600918: Cmax, Tmax, and AUC - S-600918 acyl glucronide: Cmax, Tmax, AUC, MRCmax, and MRAUC - The number and proportion of clinical and laboratory AEs in study participants exposed to single 300-mg and 1000-mg doses of S-600918	—

Measure

Time frame

pharmacokinetics safety [Part 1] - S-600918: maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-time (t1/2,z), terminal elimination rate constant (lambda z), mean residence time (MRT), apparent total clearance (CL/F), apparent volume of distribution in the terminal elimination phase (Vz/F) - S-600918 acyl glucuronide: Cmax, Tmax, AUC, t1/2,z, lambda z, metabolic ratio of Cmax for metabolite to unchanged drug (MRCmax), metabolic ratio of AUC for metabolite to unchanged drug (MRAUC) [Part 2] - Change from baseline in HR, PR, QT, and QRS (Delta HR, Delta PR, Delta QT, and Delta QRS) - Placebo-corrected Delta HR, Delta PR, Delta QT, Delta QTcF, and Delta QRS (Double-Delta HR, Double-Delta PR, Double-Delta QT, Double-Delta QTcF and Double-Delta QRS) - Categorical outliers for HR, QTcF, PR, and QRS - Frequency of treatment-emergent changes for T-wave morphology and U-wave presence - S-600918: Cmax, Tmax, and AUC - S-600918 acyl glucronide: Cmax, Tmax, AUC, MRCmax, and MRAUC - The number and proportion of clinical and laboratory AEs in study participants exposed to single 300-mg and 1000-mg doses of S-600918

—

Countries

Japan

Outcome results

None listed

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