Mass Balance Study of [14C]-S-600918 Oral Suspension in Healthy Male Subjects

A Phase I Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-S-600918 Following Oral Dose Administration in Healthy Adult Male Subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225285

Enrollment

Registered

2020-07-20

Start date

2020-08-20

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

Male

Inclusion criteria

Inclusion criteria: Healthy male subjects

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetics - Total radioactivity (TR) in all excreta (urine and faeces): Cumulative amount of TR excreted in excreta (CumAe) and CumAe expressed as a percentage of the radioactive dose administered (Cum%Ae) - Concentrations of TR in whole blood and plasma - Pharmacokinetics (PK) parameters for TR, S-600918 and S-600918 acyl glucuronide in plasma for TR in whole blood including but not limited to: time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the concentration-time curve (AUC)	—

Measure

Time frame

pharmacokinetics - Total radioactivity (TR) in all excreta (urine and faeces): Cumulative amount of TR excreted in excreta (CumAe) and CumAe expressed as a percentage of the radioactive dose administered (Cum%Ae) - Concentrations of TR in whole blood and plasma - Pharmacokinetics (PK) parameters for TR, S-600918 and S-600918 acyl glucuronide in plasma for TR in whole blood including but not limited to: time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the concentration-time curve (AUC)

—

Secondary

Measure	Time frame
safety pharmacokinetics - Amount of TR excreted in excreta (Ae) and Ae expressed as a percentage of the radioactive dose administered (%Ae), CumAe and Cum%A by interval in urine, faeces, and urine and faeces combined, and appropriate PK parameters of TR, S-600918 and S-600918 acyl glucuronide in plasma and TR in whole blood. - Each metabolite accounting for more than 5% (in plasma) by AUC of circulating TR and each metabolite in excreta (urine and faeces) that account for more than 10% of the administered radioactive dose - Whole blood:plasma concentration ratios for TR. - Adverse events (AEs), vital signs, ECGs, physical examinations and laboratory safety tests.	—

Measure

Time frame

safety pharmacokinetics - Amount of TR excreted in excreta (Ae) and Ae expressed as a percentage of the radioactive dose administered (%Ae), CumAe and Cum%A by interval in urine, faeces, and urine and faeces combined, and appropriate PK parameters of TR, S-600918 and S-600918 acyl glucuronide in plasma and TR in whole blood. - Each metabolite accounting for more than 5% (in plasma) by AUC of circulating TR and each metabolite in excreta (urine and faeces) that account for more than 10% of the administered radioactive dose - Whole blood:plasma concentration ratios for TR. - Adverse events (AEs), vital signs, ECGs, physical examinations and laboratory safety tests.

—

Countries

Europe

Outcome results

None listed

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