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A Study to Assess the Effect of S-600918 on the Pharmacokinetics of Fexofenadine, Rosuvastatin, and Atorvastatin in Healthy Adult Subjects

A Study to Assess the Effect of S-600918 on the Pharmacokinetics of Fexofenadine, Rosuvastatin, and Atorvastatin in Healthy Adult Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224683
Enrollment
42
Registered
2019-05-15
Start date
2019-05-17
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 : - Therapeutic category code : 222 Antitussives Dosage and Administration for Investigational material : Oral

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

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 significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immune, neurological or psychiatric disorders, or other clinically significant diseases.

Design outcomes

Primary

MeasureTime frame
pharmacokinetics Maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), area under the concentration-time curve from time zero to the time of the last quantifiable concentration after dosing (AUC0-last), area under the concentration-time curve extrapolated from time zero to infinity (AUC0-inf), 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)

Secondary

MeasureTime frame
safety Treatment-emergent adverse events (TEAEs), physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms

Countries

Japan

Outcome results

None listed

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