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

Phase I study of KRP-AM1977X- Intrapulmonary pharmacokinetics of AM-1977 in healthy volunteer subjects -

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222496

Enrollment

Registered

2014-05-23

Start date

2014-02-13

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 : KRP-AM1977X INN of investigational material : lascufloxacin Therapeutic category code : 611 Antibiotic preparations acting mainly on gram-positive bacter

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Japanese healthy adult male - Never smoker, etc.

Exclusion criteria

Exclusion criteria: - Healthy volunteer Person with a medical history, surgergicaly history and disease that are unsuitable for clinical trials - An excessive drinker or a person who cannot stop drinking during a rule period, etc.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Pharmacokinetics The concentration of AM-1977 in bronchoalveolar lavage fluid and alveolar macrophage	—

Secondary

Measure	Time frame
safety Safety Adverse events and side effects	—

Countries

Japan

Outcome results

None listed

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