A Study of LY110140 in Healthy Japanese Male Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: LY110140; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569126

B1Y-JE-HCLX (Other Identifier)

14638

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 6 patient groups, including a placebo group

5 milligrams (mg) LY110140 (SD)

Experimental group

Description:

5 mg administered once in the fasted state on Day 1

Treatment:

Drug: LY110140

20 mg LY110140 (SD)

Experimental group

Description:

20 mg administered once in the fasted state on Day 1

Treatment:

Drug: LY110140

40 mg LY110140 (SD)

Experimental group

Description:

40 mg administered once in the fasted state on Day 1

Treatment:

Drug: LY110140

Placebo (MD)

Placebo Comparator group

Description:

Placebo once daily oral dosing for 28 consecutive days

Treatment:

Drug: Placebo

20 mg LY110140 (MD)

Experimental group

Description:

20 mg once daily oral dosing for 28 consecutive days

Treatment:

Drug: LY110140

40 mg LY110140 (MD)

Experimental group

Description:

40 mg once daily oral dosing for 28 consecutive days

Treatment:

Drug: LY110140