Phase I study of KRP-AM1977X (Clinical pharmacological study)

Phase I study of KRP-AM1977X -Penetration of AM-1977 into otorhinolaryngological tissues-

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222747

Enrollment

Registered

2015-02-09

Start date

2015-02-27

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

Patients with having otorhinolaryngological surgery

Interventions

investigational material(s) Generic name etc : KRP-AM1977X INN of investigational material : lascufloxacin Therapeutic category code : 624 Synthetic antibacterials Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Person with BMI that is more than 18.5 but less than 30.0, etc.

Exclusion criteria

Exclusion criteria: - Have a history of allergy or severe side effects to quinolone antibiotics. -Have a presence of severe renal dysfunction or significant hepatic disorder etc.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Pharmacokinetics Concentration of AM1977 in blood plasma	—

Secondary

Measure	Time frame
safety Safety, etc. Adverse events and side effects, etc.	—

Countries

Japan

Outcome results

None listed

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