A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects
- Conditions
- Healthy Volumteer
- Registration Number
- JPRN-jRCT2080221755
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- Not specified
[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]
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method