Phase 1
Completed N=56
A Study of LY110140 in Healthy Japanese Male Participants
Healthy Volunteer
Source: ClinicalTrials.gov NCT01569126 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period |
1; 0; 2; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140 |
NA; 15.5; 38.7; 2.44; 13.0; 22.8 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140 |
NA; 371; 1360; 195; 3000; 5850 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140 |
NA; 424; 1430; 407; 3360; 6360 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140 |
16.9; 39.9; 92.9; 284; 10.6; 18.3 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140 |
228; 574; 199; 337 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140 |
1810; 5910; 3010; 4910 | — |
| SECONDARY Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals |
1; 2; 2; 2; 3; 6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01569126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.