Clinical trial NCT01569126: A Study of LY110140 in Healthy Japanese Male Participants
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period
timeFrame: Baseline up to Day 43
measure: Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period
timeFrame: Baseline up to Day 70
Secondary outcomes:
measure: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140
timeFrame: Predose up to Day 43
measure: Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140
timeFrame: Predose up to Day 43
measure: Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140
timeFrame: Predose up to Day 43
measure: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140
timeFrame: Days 1 and 28
measure: Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140
timeFrame: Day 1
measure: Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140
timeFrame: Predose up to Day 28
measure: Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals
timeFrame: Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: