A Study of LY110140 in Healthy Japanese Male Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01569126
First received: March 30, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: LY110140
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine during the SD period is reported.

  • Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-tlast) of plasma total fluoxetine and norfluoxetine during the SD period is reported.

  • Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-infinity) of plasma total fluoxetine and norfluoxetine during the SD period is reported.

  • Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140 [ Time Frame: Days 1 and 28 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine on Day 1 and Day 28 of the MD period is reported.

  • Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-24) of plasma total fluoxetine and norfluoxetine on Day 1 of the MD period is reported.

  • Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140 [ Time Frame: Predose up to Day 28 ] [ Designated as safety issue: No ]
    Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(tau,steady state) of plasma total fluoxetine and norfluoxetine during the MD period is reported.

  • Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals [ Time Frame: Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period) ] [ Designated as safety issue: Yes ]
    The number of participants with a maximum increase from baseline in 12-lead electrocardiogram (ECG) QTcB and QTcF intervals >30 milliseconds (ms) and >60 ms for the single-dose (SD) and multiple-dose (MD) periods is reported.


Enrollment: 56
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 milligrams (mg) LY110140 (SD)
5 mg administered once in the fasted state on Day 1
Drug: LY110140
Administered orally as capsules
Other Name: Fluoxetine Hydrochloride, Prozac, Sarafem
Experimental: 20 mg LY110140 (SD)
20 mg administered once in the fasted state on Day 1
Drug: LY110140
Administered orally as capsules
Other Name: Fluoxetine Hydrochloride, Prozac, Sarafem
Experimental: 40 mg LY110140 (SD)
40 mg administered once in the fasted state on Day 1
Drug: LY110140
Administered orally as capsules
Other Name: Fluoxetine Hydrochloride, Prozac, Sarafem
Placebo Comparator: Placebo (MD)
Placebo once daily oral dosing for 28 consecutive days
Drug: Placebo
Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm
Experimental: 20 mg LY110140 (MD)
20 mg once daily oral dosing for 28 consecutive days
Drug: LY110140
Administered orally as capsules
Other Name: Fluoxetine Hydrochloride, Prozac, Sarafem
Experimental: 40 mg LY110140 (MD)
40 mg once daily oral dosing for 28 consecutive days
Drug: LY110140
Administered orally as capsules
Other Name: Fluoxetine Hydrochloride, Prozac, Sarafem

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569126

Locations
Japan
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, Japan, 532-0003
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01569126     History of Changes
Other Study ID Numbers: 14638, B1Y-JE-HCLX
Study First Received: March 30, 2012
Results First Received: September 20, 2013
Last Updated: January 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014