A Study of LY110140 in Healthy Japanese Male Participants

NCT01569126 | Completed Phase 1 Results

• 2 other identifiers: 14638B1Y-JE-HCLX
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period

  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.

  Baseline up to Day 43

• Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period

  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.

  Baseline up to Day 70

Secondary Outcomes (7)

• 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

• Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140

  Day 1

Study Arms (6)

5 milligrams (mg) LY110140 (SD)

EXPERIMENTAL

5 mg administered once in the fasted state on Day 1

Drug: LY110140

20 mg LY110140 (SD)

EXPERIMENTAL

20 mg administered once in the fasted state on Day 1

Drug: LY110140

40 mg LY110140 (SD)

EXPERIMENTAL

40 mg administered once in the fasted state on Day 1

Drug: LY110140

Placebo (MD)

PLACEBO COMPARATOR

Placebo once daily oral dosing for 28 consecutive days

Drug: Placebo

20 mg LY110140 (MD)

EXPERIMENTAL

20 mg once daily oral dosing for 28 consecutive days

Drug: LY110140

40 mg LY110140 (MD)

EXPERIMENTAL

40 mg once daily oral dosing for 28 consecutive days

Drug: LY110140

Interventions

LY110140 DRUG

Administered orally as capsules

Also known as: Fluoxetine Hydrochloride, Prozac, Sarafem

20 mg LY110140 (MD); 20 mg LY110140 (SD); 40 mg LY110140 (MD); 40 mg LY110140 (SD); 5 milligrams (mg) LY110140 (SD)

Placebo DRUG

Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm

Placebo (MD)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Osaka, 532-0003, Japan

Location

MeSH Terms

Interventions

Fluoxetine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 2, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: November 25, 2013

Record last verified: 2014-01

Locations

JP (1)