Safety and pharmacokinetics of nebulized CS-8958

CS-8958 Clinical Pharmacology study - Safety and pharmacokinetics of nebulized laninamivir octanoate (CS-8958) after a single inhaled administration in healthy male Japanese subjects -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222944

Enrollment

Registered

2015-08-26

Start date

2015-08-31

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 volunteers

Interventions

investigational material(s) Generic name etc : CS-8958 INN of investigational material : laninamivir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) male Japanese 2) between the age of 20 and 45 3) between the BMI of 18.5 and 25.0

Exclusion criteria

Exclusion criteria: 1) Subjects with abnormal lung function tests will be excluded.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Pharmacokinetic parameters for CS-8958 and laninamivir	—

Countries

Japan

Outcome results

None listed

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