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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: September 28, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

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 [ Time Frame: Baseline up to Day 43 (SD) ] [ Designated as safety issue: Yes ]
  • Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline up to Day 70 (MD) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of Single Dose of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-tlast]) of Single Dose of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-infinity]) of Single Dose of LY110140 [ Time Frame: Predose up to Day 43 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of Multiple Doses of LY110140 [ Time Frame: Days 1 and 28 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-24]) of Multiple Dose of LY110140 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [tau, steady state]) of Multiple Dose of LY110140 [ Time Frame: Predose up to Day 28 ] [ Designated as safety issue: No ]
  • Change from Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals [ Time Frame: Baseline up to Day 43 (SD) and Baseline up to Day 70 (MD) ] [ Designated as safety issue: Yes ]

Estimated 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 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 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
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
Last Updated: September 28, 2012
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 17, 2012