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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221755
Enrollment
Unknown
Registered
2012-04-04
Start date
2012-04-04
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 Volumteer

Interventions

investigational material(s) Generic name etc : LY110140 INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material :

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: [Inclusion Criteria] * Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product. * Have a body mass index (BMI) of 18.5 to 29.9kg/m^2, inclusive, at the time of screening. * Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

Exclusion criteria

Exclusion criteria: [Exclusion Criteria] * Poor metabolizers of enzyme Cytochrome P450 2D6 (CYP2D6) (assessed at screening). * Have an abnormality in the 12-lead Electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT(QTcB) intercal >450 millisecounds (msec). * Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS). * Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.

Outcome results

None listed

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