A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- LY110140
- Conditions
- Healthy Volunteer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.
Investigators
Eligibility 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 29.9 kilograms per square meter (kg/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 isoenzyme 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) interval \>450 milliseconds (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.
Arms & Interventions
20 mg LY110140 (SD)
20 mg administered once in the fasted state on Day 1
Intervention: LY110140
5 milligrams (mg) LY110140 (SD)
5 mg administered once in the fasted state on Day 1
Intervention: LY110140
40 mg LY110140 (SD)
40 mg administered once in the fasted state on Day 1
Intervention: LY110140
Placebo (MD)
Placebo once daily oral dosing for 28 consecutive days
Intervention: Placebo
20 mg LY110140 (MD)
20 mg once daily oral dosing for 28 consecutive days
Intervention: LY110140
40 mg LY110140 (MD)
40 mg once daily oral dosing for 28 consecutive days
Intervention: LY110140
Outcomes
Primary Outcomes
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period
Time Frame: Baseline up to Day 43
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period
Time Frame: Baseline up to Day 70
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
Secondary Outcomes
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140(Days 1 and 28)
- Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals(Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period))
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140(Day 1)
- Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140(Predose up to Day 28)