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A crossover study to investigate the relative bioavailability and the effect of food on the pharmacokinetics of a single dose of S-888711 in healthy male subjects

A crossover study to investigate the relative bioavailability and the effect of food on the pharmacokinetics of a single dose of S-888711 in healthy male subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224619
Enrollment
26
Registered
2019-03-28
Start date
2008-03-14
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

Sponsors

SHIONOGI & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Healthy adult male subjects between the ages >=20 and <40

Exclusion criteria

Exclusion criteria: The subject who has a history of nervous, gastric, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematic, and other clinically important disorder and is judged as an ineligible by the investigator or subinvestigator. The subject whose family has a history of hematic disorder.

Design outcomes

Primary

MeasureTime frame
bioavailability pharmacokinetics maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the plasma concentration-time curve (AUC), terminal elimination half-life (t1/2,z), apparent total clearance (CL/F), and mean residence time (MRT)

Secondary

MeasureTime frame
safety Adverse events (AEs), clinical laboratory tests, blood pressure, pulse rate, respiratory rate, body temperature, and ECG parameters

Countries

Japan

Outcome results

None listed

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